[Federal Register Volume 82, Number 132 (Wednesday, July 12, 2017)]
[Notices]
[Page 32221]
[FR Doc No: 2017-14572]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 173, SEC File No. 270-557, OMB Control No. 3235-0618.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Securities Act Rule 173 (17 CFR 230.173) provides a notice of
registration to investors who purchased securities in a registered
offering under the Securities Act of 1933 (15 U.S.C. 77a et seq.). A
Rule 173 notice must be provided by underwriter or dealer to each
investor who purchased securities from the underwriter or dealer. The
Rule 173 notice is not publicly available. We estimate that it takes
approximately 0.0167 hour per response to provide the information
required under Rule 173 and that the information is filed by
approximately 5,338 respondents approximately 43,546 times a year for a
total of 232,448,548 responses. We estimate that the total annual
reporting burden for Rule 173 is 3,881,891 hours (0.0167 hours per
response x 232,448,548 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collections of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection 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.
    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.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: July 7, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-14572 Filed 7-11-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23400-23401]
[FR Doc No: 2014-09497]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-27]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before May 19, 2014.

ADDRESSES: You may send comments identified by docket number FAA-2012-
0707 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Forseth, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>; or Sandra K. Long,
ARM-201, Office of Rulemaking, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591, email
<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on April 22, 2014.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2012-0707.
    Petitioner: L-3 Communications Integrated Systems, L.P.
    Section of 14 CFR Affected: Sec.  25.813(e).
    Description of Relief Sought: Petitioner requests an amendment to
Exemption No. 10686 to permit the installation of curved partition
doors to accommodate curved partition walls, the center of radius of
which are perpendicular to the floor of the Boeing Model 747-8
airplanes. The exemption allows installation of an executive interior
on private, not-for-hire, not-for-profit, not-for-common-carriage
Boeing 747-8 airplanes.

[FR Doc. 2014-09497 Filed 4-25-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Notices]
[Pages 21443-21446]
[FR Doc No: 2017-09196]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80579; File No. SR-NYSEArca-2016-120]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade
Shares of the ForceShares Daily 4X US Market Futures Long Fund and
ForceShares Daily 4X US Market Futures Short Fund Under Commentary .02
to NYSE Arca Equities Rule 8.200

May 2, 2017.

I. Introduction

    On October 17, 2016, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') 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 list and trade shares (``Shares'') of the
ForceShares Daily 4X US Market Futures Long Fund (``Fund'' or ``Long
Fund'') and ForceShares Daily 4X US Market Futures Short Fund (``Fund''
or ``Short Fund'' and, together with the Long Fund, the ``Funds'')
under Commentary .02 to NYSE Arca Equities Rule 8.200. The proposed
rule change was published for comment in the Federal Register on
November 4, 2016.\3\ On December 14, 2016, pursuant to Section 19(b)(2)
of the Act,\4\ the Commission designated a longer period within which
to approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to disapprove the
proposed rule change.\5\ On December 22, 2016, the Exchange filed
Amendment No. 1 to the proposed rule change, which replaced and
superseded the proposed rule change as originally filed. On February 1,
2017, the Commission instituted proceedings to determine whether to
approve or disapprove the proposed rule change.\6\ On February 15,
2017, the Exchange filed Amendment No. 2 to the proposed rule change,
which replaced and superseded the proposed rule change as modified by
Amendment No. 1. On April 20, 2017, the Exchange filed Amendment No. 3
to the proposed rule change, which replaced and superseded the proposed
rule change as modified by Amendment No. 2.\7\ The Commission received
no comments on the proposed rule change. This order approves the
proposed rule change, as modified by Amendment No. 3.
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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. 79201 (October 31,
2016), 81 FR 76977.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 79550, 81 FR 92892
(December 20, 2016). The Commission designated February 2, 2017 as
the date by which it shall approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to disapprove the proposed rule change.
    \6\ See Securities Exchange Act Release No. 79914, 82 FR 9625
(February 7, 2017).
    \7\ In Amendment No. 3, the Exchange: (1) Clarified the
permissible investments of the Funds; (2) clarified the prices that
will be used to calculate the net asset value (``NAV'') for each
Fund; (3) stated that the indicative fund value (``IFV'') will be
calculated and disseminated throughout the Exchange Core Trading
Session; (4) amended and clarified the description of the creation
and redemption process for the Shares; (5) added a discussion
regarding the impact on the arbitrage mechanism as a result of the
use of derivatives; (6) amended and supplemented the description of
the information that will be provided to ETP Holders through the
Information Bulletin; (7) provided information regarding the
obligations of ETP Holders to follow FINRA guidance relating to
increased sales practice and customer margin requirements applicable
to inverse, leveraged, and inverse leveraged securities; and (8)
made various technical changes. Amendment No. 3 is not subject to
notice and comment because it does not materially alter the
substance of the proposed rule change or raise unique or novel
regulatory issues. All of the amendments to the proposed rule change
are available at: https://www.sec.gov/comments/sr-nysearca-2016-120/nysearca2016120.shtml.

II. Description of the Proposed Rule Change, as Modified by Amendment
No. 3 \8\
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    \8\ The Commission notes that additional information regarding
the Trust (defined below), the Funds, their investments, and the
Shares, including investment strategies, risks, creation and
redemption procedures, fees, portfolio holdings disclosure policies,
and taxes, among other information, can be found in Amendment No. 3,
supra note 7, and the Registration Statement, infra note 9.

    The Exchange proposes to list and trade the Shares under Commentary
.02 to NYSE Arca Equities Rule 8.200, which governs the listing and
trading of Trust Issued Receipts on the Exchange. Each Fund is a
commodity pool that is a series of the ForceShares Trust
(``Trust'').\9\ ForceShares LLC will be the sponsor of the Funds
(``Sponsor''). ALPS Distributors, Inc. will be the marketing agent for
the Shares. U.S. Bank National Association will be the Funds' custodian
(``Custodian''). The Custodian will also be the registrar and transfer
agent for the Shares.
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    \9\ The Trust is registered under the Securities Act of 1933. On
September 30, 2016, the Trust filed with the Commission a
registration statement on Form S-1 under the Securities Act of 1933
relating to the Funds (File No. 333-213911) (``Registration
Statement'').
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    The Long Fund's primary investment objective is to seek daily
investment results, before fees and expenses, that correspond to
approximately four times (400%) the daily performance of the

closing settlement price for lead month (i.e., the ``near month'' or
next-to-expire) Standard & Poor's 500 Stock Price Index Futures
contracts (``Big S&P Contracts'') that are traded on the Chicago
Mercantile Exchange (``CME''). This closing settlement price is
referred to as the ``Benchmark.''\10\ The Short Fund's primary
investment objective is to seek daily investment results, before fees
and expenses, that correspond to approximately four times the inverse
(-400%) of the daily performance of the Benchmark. Each Fund will not
seek to achieve its primary investment objective over a period of time
greater than a single day.\11\
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    \10\ The design of the Funds' Benchmark is such that it will
change four times per year in connection with the expiration of the
lead month Big S&P Contracts, and each Fund's positions in S&P
Interests (defined below) will be rolled on a regular basis in order
to track the changing nature of the Benchmark.
    \11\ The Exchange states that the return of each Fund for
periods longer than a single day will be the result of each day's
returns compounded over the period, which will very likely differ
from four times the total performance, in the case of the Long Fund,
or four times the inverse of the total performance, in the case of
the Short Fund, of the Benchmark over the same period.
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    Under normal market conditions, each Fund will seek to achieve its
primary investment objective primarily by investing in Big S&P
Contracts. Each Fund will also invest in E-Mini S&P 500 Futures
contracts (``E-Minis'' and, together with Big S&P Contracts, ``Primary
S&P Interests'') to seek to achieve its primary investment objective
where position limits prevent further purchases of Big S&P Contracts.
Each Fund expects to apply approximately 10-25% of its portfolio toward
obtaining exposure to futures contracts, all of which will be lead
month or deferred month Primary S&P Interests. Subsequently, each Fund
may also invest in swap agreements (cleared and over-the-counter)
referencing Primary S&P Interests or the S&P 500 Index, and over-the-
counter forward contracts referencing Primary S&P Interests (``Other
S&P Interests'' and, together with Primary S&P Interests, ``S&P
Interests'').\12\ Each Fund may invest in Other S&P Interests in an
amount up to 25% of its net assets.
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    \12\ The Sponsor will assess or review, as appropriate, the
creditworthiness of each potential or existing counterparty to an
over-the-counter contract.
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    Each Fund may acquire or dispose of Stop Options, which will be
options on Primary S&P Interests, in pursuing its secondary investment
objective of recouping a small amount of a Fund's losses from an
extreme, short term movement in the Benchmark.\13\ Stop Options are
expected to average less than approximately 5% of each Fund's
portfolio.
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    \13\ The Long Fund will hold put options, and the Short Fund
will hold call options, with respect to all or substantially all of
its S&P Interests with strike prices at approximately 75%, in the
case of the Long Fund, or 125%, in the case of the Short Fund, of
the value of the applicable underlying S&P Interest as of the end of
the preceding business day. These Stop Options will serve primarily
to (a) prevent the Fund's NAV from going to zero in the event of a
25% adverse move in the Benchmark, and (b) recoup a small portion of
substantial losses of a Fund that may result from large movements in
the Benchmark.
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    On a day-to-day basis, each Fund will invest the remainder of its
assets in money market funds, depository accounts with institutions
with high quality credit ratings, or short-term debt instruments that
have terms-to-maturity of less than 397 days and exhibit high quality
credit profiles, including U.S. government securities and repurchase
agreements (collectively, ``Cash Equivalents''). Cash Equivalents are
expected to comprise approximately 70-85% of each Fund's portfolio.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 3, is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\14\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment No. 3, is consistent
with Section 6(b)(5) of the Act,\15\ which requires, among other
things, that the Exchange'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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    \14\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \15\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Act,\16\ which sets forth Congress's finding that it is in the
public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for, and transactions in, securities.
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    \16\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    Quotation and last-sale information for the Shares will be
disseminated through the facilities of the Consolidated Tape
Association (``CTA''). The indicative fund value (``IFV'') will be
disseminated every 15 seconds during the Exchange's Core Trading
Session.\17\ The Exchange will make available on its Web site daily
trading volume, closing prices, and the NAV of the Shares.\18\ The
Exchange will also disseminate on a daily basis via the CTA information
with respect to the NAV and Shares outstanding. Intraday and closing
price information from brokers and dealers or independent pricing
services, among other sources, will be available for S&P Interests,
Stop Options, and Cash Equivalents. The Benchmark will be disseminated
by one or more major market data vendors every 15 seconds during the
NYSE Arca Core Trading Session.
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    \17\ The Exchange will disseminate the IFV through the
facilities of the CTA high speed line. In addition, the IFV will be
published on the Exchange's Web site and will be available through
on-line information services.
    \18\ Each Fund's NAV will be calculated as of the earlier of
4:00 p.m. E.T. or the close of the Exchange each day. The NAV for a
particular trading day will be released after 4:15 p.m. E.T. The NAV
for the Funds will be disseminated daily to all market participants
at the same time.
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    On a daily basis, the Sponsor will disclose on the Funds' Web site
the following information regarding each portfolio holding, as
applicable to the type of holding: Ticker symbol, CUSIP number or other
identifier, if any; a description of the holding (including the type of
holding, such as the type of swap); the identity of the security, index
or other asset or instrument underlying the holding, if any; for
options, the option strike price; quantity held (as measured by, for
example, par value, notional value or number of shares, contracts or
units); maturity date, if any; market value of the holding; and the
percentage weighting of the holding in a Fund's portfolio.\19\ The
Funds' Web site will also include the prospectus, data relating to the
NAV, and other applicable quantitative information for each Fund.
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    \19\ The disclosure of the Funds' portfolio composition on the
Funds' Web site will occur at the same time as the disclosure by the
Sponsor of the portfolio composition to Authorized Purchasers so
that all market participants are provided portfolio composition
information at the same time.
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    The Commission also believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. If the Exchange becomes aware that the NAV with respect to the
Shares is not disseminated to all market participants at the same time,
it will halt trading in

the Shares until such time as the NAV is available to all market
participants. Trading in the Shares will also be subject to NYSE Arca
Equities Rule 7.12, which sets forth circumstances under which trading
in the Shares may be halted. In addition, trading may be halted because
of market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable.\20\ Moreover, the Exchange may
halt trading during the day in which an interruption to the
dissemination of the IFV or the value of the underlying futures
contracts occurs. If the interruption to the dissemination of the IFV
or the value of the underlying futures contracts persists past the
trading day in which it occurred, the Exchange will halt trading no
later than the beginning of the trading day following the interruption.
The Exchange represents that it has a general policy prohibiting the
distribution of material, non-public information by its employees.
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    \20\ These may include: (1) The extent to which trading is not
occurring in the underlying futures contracts; or (2) whether other
unusual conditions or circumstances detrimental to the maintenance
of a fair and orderly market are present.
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    The Exchange represents that it deems the Shares to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made the following
representations:
    (1) The Funds will meet the initial and continued listing
requirements applicable to Trust Issued Receipts in NYSE Arca Equities
Rule 8.200 and Commentary .02 thereto.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) Trading in the Shares will be subject to the existing trading
surveillances administered by the Exchange, as well as cross-market
surveillances administered by the Financial Industry Regulatory
Authority (``FINRA'') on behalf of the Exchange, and these procedures
are adequate to properly monitor Exchange trading of the Shares in all
trading sessions and to deter and detect violations of Exchange rules
and applicable federal securities laws.\21\
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    \21\ The Exchange states that FINRA conducts cross-market
surveillances on behalf of the Exchange pursuant to a regulatory
services agreement, and that the Exchange is responsible for FINRA's
performance under this regulatory services agreement.
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    (4) The Exchange or FINRA, on behalf of the Exchange, or both, will
communicate as needed regarding trading in the Shares, Primary S&P
Interests, and options on futures with other markets or other entities
that are members of the Intermarket Surveillance Group (``ISG''), and
the Exchange or FINRA, on behalf of the Exchange, or both, may obtain
trading information regarding trading in such securities and financial
instruments from such markets or entities. In addition, the Exchange
may obtain information regarding trading in such securities and
financial instruments from markets or other entities that are members
of ISG or with which the Exchange has in place a comprehensive
surveillance sharing agreement (``CSSA'').
    (5) Not more than 10% of the net assets of a Fund in the aggregate
invested in futures contracts or exchange-traded options contracts
shall consist of futures contracts or exchange-traded options contracts
whose principal market is not a member of ISG or is a market with which
the Exchange does not have a CSSA.
    (6) Prior to the commencement of trading, the Exchange will inform
its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (a)
The risks involved in trading the Shares during the Opening and Late
Trading Sessions when an updated IFV will not be calculated or publicly
disseminated; (b) the procedures for purchases and redemptions of
Shares in Creation Baskets and Redemption Baskets (and that Shares are
not individually redeemable); (c) NYSE Arca Equities Rule 9.2(a), which
imposes a duty of due diligence on its ETP Holders to learn the
essential facts relating to every customer prior to trading the Shares;
(d) how information regarding the IFV and the portfolio is
disseminated; (e) applicable prospectus delivery requirements; and (f)
trading information.
    (7) Prior to the commencement of trading, the Exchange will inform
its ETP Holders of the suitability requirements of NYSE Arca Equities
Rule 9.2(a) in an Information Bulletin. Specifically, ETP Holders will
be reminded in the Information Bulletin that, in recommending
transactions in the Shares, they must have a reasonable basis to
believe that (a) the recommendation is suitable for a customer given
reasonable inquiry concerning the customer's investment objectives,
financial situation, needs, and any other information known by such ETP
Holder, and (b) the customer can evaluate the special characteristics,
and is able to bear the financial risks, of an investment in the
Shares. In connection with the suitability obligation, the Information
Bulletin will also provide that ETP Holders must make reasonable
efforts to obtain the following information: (a) The customer's
financial status; (b) the customer's tax status; (c) the customer's
investment objectives; and (d) such other information used or
considered to be reasonable by such ETP Holder or registered
representative in making recommendations to the customer.
    (8) A minimum of 100,000 Shares for each Fund will be outstanding
at the start of trading on the Exchange.
    The Exchange represents that all statements and representations
made in the filing regarding (a) the description of the portfolios; (b)
limitations on portfolio holdings or reference assets; or (c) the
applicability of Exchange listing rules specified in the rule filing
constitute continued listing requirements for listing the Shares on the
Exchange. In addition, the issuer has represented to the Exchange that
it will advise the Exchange of any failure by a Fund to comply with the
continued listing requirements and, pursuant to its obligations under
Section 19(g)(1) of the Act, the Exchange will monitor \22\ for
compliance with the continued listing requirements. If a Fund is not in
compliance with the applicable listing requirements, the Exchange will
commence delisting procedures under NYSE Arca Equities Rule 5.5(m).
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    \22\ The Commission notes that certain proposals for the listing
and trading of exchange-traded products include a representation
that the exchange will ``surveil'' for compliance with the continued
listing requirements. See, e.g., Securities Exchange Act Release No.
77499 (April 1, 2016), 81 FR 20428, 20432 (April 7, 2016) (SR-BATS-
2016-04). In the context of this representation, it is the
Commission's view that ``monitor'' and ``surveil'' both mean ongoing
oversight of compliance with the continued listing requirements.
Therefore, the Commission does not view ``monitor'' as a more or
less stringent obligation than ``surveil'' with respect to the
continued listing requirements.
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    This approval order is based on all of the Exchange's statements
and representations, including those set forth above and in Amendment
No. 3.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment No. 3, is consistent with Section
6(b)(5) of the Act \23\ and Section 11A(a)(1)(C)(iii) of the Act \24\
and the rules and regulations thereunder applicable to a national
securities exchange.
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    \23\ 15 U.S.C. 78f(b)(5).
    \24\ 15 U.S.C. 78k-1(a)(1)(C)(iii).

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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\25\ that the proposed rule change (SR-NYSEArca-2016-120), as
modified by Amendment No. 3, be, and it hereby is, approved.
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    \25\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-09196 Filed 5-5-17; 8:45 am]
BILLING CODE 8011-01-P


BEFORE

THE DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C. 20590

In the matter of 					)

 							)

 INTRA-ALASKA MAIL RATES		) 	DOCKET OST-03-14694

							) 	DOCKET OST-03-14695

Order 2004-2-12 setting final mail rates		)

Bering Air Notice to Equalize Mail Rates

Bering Air, Inc., an Alaskan Air Carrier currently authorized to
transport United States Mail, hereby gives notice of its intent to
equalize its mail rates to the lowest lawful rate in the following
markets effective February 13, 2004:

Nome and Savoonga

Nome and Gambell

Kotzebue and Noatak

Kotzebue Point Hope.

This written notice will remain in effect until terminated by written
notice.

Whereas Bering Air, Inc. gives this notice of equalization of its mail
rates, Bering Air, Inc. requests equitable tender of mail in the above
markets pursuant to the provisions of the rural Service Improvement Act
and the practices and procedures of the Department of Transportation and
the United States Postal Service.

Respectfully submitted,

Allen Haddadi

General Manager, Bering Air

February 19, 2004

Cc: Steve Deaton - USPS


[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76095-76097]
[FR Doc No: 2022-26865]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96452; File No. SR-NASDAQ-2022-069]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Equity 4, Rule 4753 and Equity 4, Rule 4703

December 6, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 25, 2022, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to clarify when Immediate or Cancel Orders
for halted securities are cancelled by amending Equity 4, Rule 4753 and
Equity 4, Rule 4703. The text of the proposed rule change is available
on the Exchange's website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    First, the Exchange proposes to amend Equity 4, Rule 4753,\3\ which
governs the Nasdaq Halt Cross process, to clarify the Exchange's
existing practice that (1) any IOC Order for a halted security that is
entered prior to the Nasdaq Closing Cross and for which the halt
remains in effect at the commencement of the Nasdaq Closing Cross, is
cancelled immediately after the Nasdaq Closing Cross; and (2) any IOC
Order for a halted security that is entered after the Nasdaq Closing
Cross and for which the halt remains in effect at 8:00 p.m. ET (or 5:00
p.m. ET in the event of a Scheduled Early Close), is cancelled at 8:00
p.m. ET (or 5:00 p.m. ET in the event of a Scheduled Early Close).
Second, the Exchange proposes to delete the Time-in-Force definition of
``System Hours Immediate or Cancel'' or ``SIOC'' contained in Equity 4,
Rule 4703(a)(1) to avoid confusion. Finally, the Exchange proposes
adding a cross-reference to Rule 4703(a)(1), which would reference the
new language in Rule 4753.
---------------------------------------------------------------------------

    \3\ Hereinafter, references to the Rule 4000 Series shall mean
the Rule Series set forth in Equity 4 of the Exchange's Rulebook.
---------------------------------------------------------------------------

    An Order with a Time in Force of ``Immediate or Cancel'' or ``IOC''
is designated to deactivate or execute, as applicable, immediately
after determining whether the Order is marketable. However, if an IOC
Order is entered for a halted security, the System cannot determine the
marketability of the Order. Assuming trading of the halted security
does not resume, the Order is cancelled, either after the Nasdaq
Closing Cross if the Order is entered prior to the Nasdaq Closing Cross
or at 8:00 p.m. ET (or 5:00 p.m. ET in the event of a Scheduled Early
Close) if the Order is entered after the Nasdaq Closing Cross. The
proposed rule change is specific to IOC Orders for halted securities
(for which a halt cross will occur).\4\
---------------------------------------------------------------------------

    \4\ During any trading halt or pause for which a halt cross
under Rule 4753 will not occur, orders entered during the trading
halt or pause are not accepted, unless subject to instructions that
the order will be directed to another exchange as described in Rule
4758. Rule 4120(c)(4)(B).
---------------------------------------------------------------------------

    When an IOC Order for a halted security is received prior to the
Nasdaq Closing Cross, the Order remains valid until the Nasdaq Closing
Cross. If the security remains halted at the commencement of the Nasdaq
Closing Cross, the Exchange cancels the Order immediately after the
Nasdaq Closing Cross. For example, consider Stock A is halted at 11:00
a.m. ET. The Exchange receives an IOC Order for Stock A at 2:00 p.m.
ET. The Nasdaq Closing Cross commences at 4:00 p.m. ET and Stock A
remains halted. The IOC Order for Stock A is cancelled immediately
after the Nasdaq Closing Cross. This practice is consistent with
customer expectations and how the Exchange currently operates. If the
halt is lifted prior to the Nasdaq Closing Cross, the Orders execute in
the re-opening auction, if marketable, or otherwise cancel. To the
extent the halt remains in place at the commencement of the Nasdaq
Closing Cross, participants do not expect the Orders to remain eligible
after hours and therefore, expect the IOC Orders to expire immediately
after the Nasdaq Closing Cross.\5\ If the IOC Order for Stock A
described above was not cancelled after the Nasdaq Closing Cross and
the halt was lifted in the extended trading hours, the Order could get
filled at an unexpected price, particularly during extended trading
hours when many securities are thinly traded.
---------------------------------------------------------------------------

    \5\ This is akin to the Exchange's practice to deactivate day
orders after the Nasdaq Closing Cross. See Rule 4703(a)(5). The
practice is also consistent with the definition of ``Market Hours
Immediate of Cancel'' or ``MIOC.'' See Rule 4703(a)(1).
---------------------------------------------------------------------------

    When an IOC Order for a halted security is received after the
Nasdaq Closing Cross, the Order remains valid until 8:00 p.m. ET (or
5:00 p.m. ET in the event of a Scheduled Early Close). If the security
remains halted at 8:00 p.m. ET (or 5:00 p.m. ET in the event of a
Scheduled Early Close), the Exchange cancels the Order at 8:00 p.m. ET
(or 5:00 p.m. ET in the event of a Scheduled Early Close). For example,
consider Stock A is halted at 11:00 a.m. ET. The Exchange receives an
IOC Order for Stock A at 4:01 p.m. ET, after the Nasdaq Closing Cross.
In this example, the IOC Order for Stock A remains valid until 8:00
p.m. ET. If the security remains halted at 8:00 p.m. ET, the Order is
cancelled at that time. This practice is consistent with customer
expectations and how the Exchange currently operates. Participants who
enter IOC Orders for halted securities after the Nasdaq Closing Cross
intend for the Order to be eligible for execution in the extended hours
session, ending at 8:00 p.m. ET (or 5:00 p.m. ET in the event of a
Scheduled Early Close). If the Orders were not cancelled, the security
may resume trading and the Order may be filled at a price not expected
by the customer.
    Notwithstanding the absence of express language in the Rules, the

Exchange believes that the current practice is consistent with customer
expectations. The Exchange is aware of no customer confusion on the
issue. Nevertheless, the Exchange believes that the existing Rules
would benefit from clarification so as to avoid the potential for any
confusion in the future. Accordingly, the Exchange proposes to add a
new section (e) to Rule 4753 to codify the existing practice.
    In addition, the Exchange proposes to delete the Time-in-Force
definition of ``System Hours Immediate or Cancel'' or ``SIOC'' from
Equity 4, Rule 4703(a)(1). Specifically, the Exchange proposes to
delete the following language:

    An Order with a Time-in-Force of IOC that is entered at any time
between 4:00 a.m. ET and 8:00 p.m. ET may be referred to as having a
Time-in-Force of ``System Hours Immediate or Cancel'' or ``SIOC''.

    The defined term ``System Hours Immediate or Cancel'' or ``SIOC''
is not referenced elsewhere in Nasdaq's Rules. Moreover, the language
and purpose thereof are unclear. The Exchange believes that the
language should be deleted to avoid confusion as the definitions of
``Market Hours Immediate or Cancel'' or ``MIOC'' and SIOC include
overlapping hours. Furthermore, in the case of IOC Order for halted
securities, the SIOC definition does not make clear the current
practice that any IOC Order for a halted security that is entered prior
to the Nasdaq Closing Cross is cancelled immediately after the Nasdaq
Closing Cross if the security remains halted at the commencement of the
Nasdaq Closing Cross. The Exchange also proposes adding a cross-
reference to Rule 4703(a)(1), which would reference the new language in
Rule 4753. The Exchange believes that the proposed deletion and cross-
reference in Rule 4703, coupled with proposed Rule 4753(e), would help
to avoid the potential for any confusion in the future.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed 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.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that it is just and equitable, and in the
interests of the public and investors, for the Exchange to (1) remove
unnecessary language from and add a cross-reference in Rule 4703 and
(2) amend Rule 4753 to clarify the Exchange's existing practice to
cancel IOC Orders for halted securities as described above. The
Exchange believes that the public and investors will benefit from
increased clarity, which will help limit any potential confusion in the
future.
    The Exchange also believes that the Exchange's existing practice
that (1) any IOC Order for a halted security that is entered prior to
the Nasdaq Closing Cross and for which the halt remains in effect at
the commencement of the Nasdaq Closing Cross, is cancelled immediately
after the Nasdaq Closing Cross; and (2) any IOC Order for a halted
security that is entered after the Nasdaq Closing Cross and for which
the halt remains in effect at 8:00 p.m. ET (or 5:00 p.m. ET in the
event of a Scheduled Early Close), is cancelled at 8:00 p.m. ET (or
5:00 p.m. ET in the event of a Scheduled Early Close) is consistent
with the protection of investors and the public interest. This practice
is consistent with both current practice and investor expectations. It
helps to avoid unexpected executions that might occur if such Orders
are not cancelled and there are significant changes in the price of the
security once the halt is lifted, thereby protecting investors and the
public interest. Furthermore, the Exchange believes that codifying its
current practice to cancel IOC Orders for halted securities as
described above, consistent with customer expectations, is designed to
promote just and equitable principles of trade and remove impediments
to and perfect the mechanisms of a free and open market as it adds
clarity to the Exchange's Rules and avoids the potential for any
confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposal merely codifies
and clarifies an existing practice of the Exchange to cancel IOC Orders
for halted securities immediately after the Nasdaq Closing Cross in the
case of an Order entered prior to the Nasdaq Closing Cross where the
security remains halted upon commencement of the Nasdaq Closing Cross
and at 8:00 p.m. ET (or 5:00 p.m. ET in the event of a Scheduled Early
Close) in the case of an Order entered after the Nasdaq Closing Cross
where the security remains halted at 8:00 p.m. ET (or 5:00 p.m. ET in
the event of a Scheduled Early Close). The Exchange would also make
technical changes to improve the clarity of the proposal. The proposed
changes are designed to more clearly describe an existing practice and
make technical and conforming changes to the Rules without changing
existing practice and, therefore, the Exchange believes that the
proposed changes will not impose a burden on competition.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6) \9\ thereunder.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The proposed
rule text codifies the Exchange's current practice of handling IOC
orders for halted securities. In addition, it clarifies the Exchange's
rules by deleting a term not used elsewhere and adding a cross-
reference. The Commission believes that the proposed rule change does
not raise any new or novel issues, and waiver of the 30-day operative
delay is consistent with the protection of investors and the public
interest. Accordingly, the Commission hereby waives the

operative delay and designates the proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\14\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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 email to [email protected]. Please include
File Number SR-NASDAQ-2022-069.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2022-069. This
file number should be included on the subject line if email 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 website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2022-069, and should be submitted
on or before January 3, 2023.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-26865 Filed 12-9-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 112 (Wednesday, June 10, 2020)]
[Notices]
[Page 35421]
[FR Doc No: 2020-12543]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER20-1668-001.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Tariff Amendment: LGIP Modification Date Extension to
be effective 6/28/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5054.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1975-001.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: Correction to Notice of Termination
of GIA & DSA SA Nos. 875 and 876 to be effective 6/4/2020.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5107.
    Comments Due: 5 p.m. ET 6/24/20.

    Docket Numbers: ER20-1985-000.
    Applicants: Northern Colorado Wind Energy Center, LLC.
    Description: Baseline eTariff Filing: Northern Colorado Wind Energy
Center, LLC MBR Application to be effective 7/23/2020.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5144.
    Comments Due: 5 p.m. ET 6/24/20.

    Docket Numbers: ER20-1986-000.
    Applicants: Day County Wind I, LLC.
    Description: Baseline eTariff Filing: Day County Wind I, LLC
Application for MBR Authority to be effective 8/3/2020.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5145.
    Comments Due: 5 p.m. ET 6/24/20.

    Docket Numbers: ER20-1987-000.
    Applicants: Cerro Gordo Wind, LLC.
    Description: Baseline eTariff Filing: Cerro Gordo Wind, LLC
Application for MBR Authority to be effective 8/3/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5000.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1988-000.
    Applicants: Northern Colorado Wind Energy Center II, LLC.
    Description: Baseline eTariff Filing: Northern Colorado Wind Energy
Center II, LLC MBR Application to be effective 7/24/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5056.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1989-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2020-06-04 Certificate of
Concurrence--LGIA among Luz Solar, SCE & CAISO to be effective 5/30/
2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5087.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1990-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-PEMC Wholesale Contract
Revisions to Rate Schedule No. 172 to be effective 6/1/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5088.
    Comments Due: 5 p.m. ET 6/25/20.

    Docket Numbers: ER20-1991-000.
    Applicants: Ponderosa Wind, LLC.
    Description: Baseline eTariff Filing: Ponderosa Wind, LLC
Application for MBR Authority to be effective 8/4/2020.
    Filed Date: 6/4/20.
    Accession Number: 20200604-5096.
    Comments Due: 5 p.m. ET 6/25/20.

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

    Docket Numbers: ES20-42-000.
    Applicants: Consumers Energy Company.
    Description: Application Under Section 204 of the Federal Power Act
for Authorization to Issue Securities of Consumers Energy Company.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5158.
    Comments Due: 5 p.m. ET 6/24/20.

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

    Dated: June 4, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-12543 Filed 6-9-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59401-59404]
[FR Doc No: 2011-24581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0275]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Certification to
Accompany Drug, Biological Product, and Device Applications or
Submissions (Form FDA 3674)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
26, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0616.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Certification to Accompany Drug, Biological
Product, and Device Applications or Submissions

(Form FDA 3674)--(OMB Control Number 0910-0616)--Extension

    The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in
the form of a certification, Form FDA 3674, which accompanies
applications and submissions currently submitted to FDA and is already
approved by OMB. The OMB control numbers and expiration dates for
submitting Form FDA 3674 under the following parts are: 21 CFR parts
312 and 314 (human drugs) are 0910-0014, expiring August 31, 2011, and
0910-0001, expiring May 31, 2011; 21 CFR parts 312 and 601 (biological
products) are 0910-0014 and 0910-0338, expiring December 31, 2011; 21
CFR parts 807 and 814 (devices) are 0910-0120, expiring December 31,
2013, and 0910-0231, expiring December 31, 2013.
    Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j) (42 U.S.C. 282(j)). The provisions require additional
information to be submitted to the clinical trials data bank (http://ClinicalTrials.gov) \1\ previously established by the National
Institutes of Health (NIH)/National Library of Medicine, including
expanded information on clinical trials and information on the results
of clinical trials. The provisions include responsibilities for FDA as
well as several amendments to the Federal Food, Drug, and Cosmetic Act
(the FD&C Act).
---------------------------------------------------------------------------

    \1\ FDA has verified the Web site addresses throughout this
document, but FDA is not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.
---------------------------------------------------------------------------

    One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers.
    The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
    The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed

provisions of the FD&C Act or the PHS Act adhere to the appropriate
legal and regulatory requirements for certifying to having complied
with those requirements. The failure to submit the certification
required by section 402(j)(5)(B) of the PHS Act, and the knowing
submission of a false certification are both prohibited acts under
section 301 of the FD&C Act (21 U.S.C. 331). Violations are subject to
civil money penalties.
    In January 2009, FDA issued ``Guidance for Sponsors, Industry,
Researchers, Investigators, and Food and Drug Administration Staff
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions: Compliance with Section 402(j) of The Public
Health Service Act, Added By Title VIII of The Food and Drug
Administration Amendments Act of 2007'' available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This
guidance identified the applications and submissions that FDA
considered should be accompanied by the certification form, Form FDA
3674. The applications and submissions noted in the guidance are
reflected in the burden analysis.

I. Investigational New Drug Applications

    FDA's Center for Drug Evaluation and Research (CDER) received 1,752
investigational new drug applications (INDs) and 11,769 clinical
protocol IND amendments in fiscal year (FY) 2010. CDER anticipates that
IND and clinical protocol amendment submission rates will remain at or
near this level in the near future.
    FDA's Center for Biologics Evaluation and Research (CBER) received
281 new INDs and 1,471 clinical protocol IND amendments in FY 2010.
CBER anticipates that IND and clinical protocol amendment submission
rates will remain at or near this level in the near future.
    The estimated total number of submissions (new INDs and new
protocol submissions) subject to mandatory certification requirements
under section 402(j)(5)(B) of the PHS Act, is 13,521 for CDER plus
1,752 for CBER, or 15,273 submissions per year. The minutes per
response is the estimated number of minutes that a respondent would
spend preparing the information to be submitted to FDA under section
402(j)(5)(B) of the PHS Act, including the time it takes to enter the
necessary information on the form.
    Based on its experience with current submissions, FDA estimates
that approximately 15.0 minutes on average would be needed per response
for certifications which accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a NCT number from
http://ClinicalTrials.gov prior to making the submission to FDA. It is
also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.

II. Marketing Applications/Submissions

    In 2010, CDER and CBER received 165 new drug applications (NDA)/
biologics license applications (BLA)/resubmissions and 1,483 NDA/BLA
amendments for which certifications are needed. CDER and CBER received
191 efficacy supplements/resubmissions to previously approved NDAs/BLAs
in FY 2010. CDER and CBER anticipate that new drug/biologic
applications/resubmissions and efficacy supplement submission rates
will remain at or near this level in the near future.
    FDA's Center for Devices and Radiological Health (CDRH) received a
total of 892 new applications for premarket approvals (PMA), 510(k)
submissions containing clinical information, PMA supplements,
applications for humanitarian device exemptions (HDE) and amendments,
for a total of 424 new applications/submissions in FY 2010. CDRH
anticipates that application, amendment, supplement, and annual report
submission rates will remain at or near this level in the near future.
    FDA's Office of Generic Drugs (OGD) received 854 abbreviated new
drug applications (ANDAs) in FY 2010. OGD received 495 bioequivalence
amendments/supplements FY 2010. OGD anticipates that application,
amendment, and supplement submission rates will remain at or near this
level in the near future.
    Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45.0 minutes on average would be needed
per response for certifications which accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing applications and submissions. It is assumed
that the sponsor/applicant/submitter has electronic capabilities
allowing them to retrieve the information necessary to complete the
form in an efficient manner.
    In the Federal Register of May 6, 2011 (76 FR 26305), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. There were four comments submitted in response to the 60-
day Federal Register notice. Only two comments were directly related to
the information collection. One comment was unrelated to the
information collection. The remaining comment requested that FDA define
a term contained in section 402(j)(1)(A)(ii) of the PHS Act (42 U.S.C.
282(j)(1)(A)(ii)). The implementation of this provision, including
defining any statutory terms, is the responsibility of NIH. NIH has
indicated in the Unified Agenda that proposed rulemaking is anticipated
in 2011. In addition, NIH has provided an elaboration of the definition
of that term on its Web site at http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.
    One of the comments that directly addressed the information
collection commented on the utility of the information collected
through Form FDA 3674 and requested that FDA consider a means to
associate the NCT number with the study numbers. Since the enactment of
FDAAA, FDA has been involved in a technological effort designed to
accomplish what has been suggested by the comment. FDA is currently
involved in designing a software/computer system that can link the
information provided on the Form FDA 3674 with actions taken in
relation to that study, a future marketing application, and future
actions taken in relation to the approved medical product. Part of this
effort is designed to provide NIH information which will be displayed
on its Web site for each clinical trial for which specific information
is provided. An additional aspect for the effort is designed to link
this information internally for various purposes including compliance
efforts. This commenter also proposed changes to the timing of the
certification submissions accompanying INDs based upon the requirements
for submission of clinical trial information to http://ClinicalTrials.gov. FDA appreciates the comment but has implemented the
statutory requirements in the most efficient manner possible. The
statute requires FDA to obtain the certification upon submission of an
IND despite the fact that submission of clinical trial information to
http://ClinicalTrials.gov generally is not required at the time an IND
is required to be submitted. In order to collect information on trials
that are not applicable clinical trials, as suggested by the comment,
either a

statutory change or, possibly, rulemaking would be required.
    The remaining comment contended that the estimates FDA used in its
burden estimates should be adjusted significantly upward. We do not
agree with the comment's conclusions. FDA has based the burden hours on
the totality of the time needed for the information collection and not
(as claimed by the commenter) on the completion of the form itself. As
noted in our previous information collection and this one, we
anticipated that entities submitting Form FDA 3674 would implement
systems that would simplify collection of the information. We have
received feedback based on submitters' experience over the past 3\1/2\
years that suggests these types of systems have been implemented.
Furthermore, given the responsibilities required for registering and
updating trials on http://ClinicalTrials.gov and current FDA
requirements, unrelated to Form FDA 3674, for submission of trial
information for marketing applications, the information required for
completion of this form should be easy to compile. FDA's experience in
responding to calls on the form and questions presented at meetings and
conferences does not accord with the practices noted in this comment
and does not support the burden estimates proposed by the comment. In
fact, the only other comment submitted directly related to the
information collection indicated that the ``estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumption used, seems reasonable.''
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of           No. of
                                                           respondents      respondents       No. of       Total annual   Average burden
                  FDA Center activity                   (investigational    (marketing     responses per     responses     per response     Total hours
                                                          applications)    applications)    respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................................            1,752   ..............               1           1,752            0.25             438
                                                                                (15 min.)
Clinical Protocol Amendments (IND)....................           11,769   ..............               1          11,769            0.25           2,943
                                                                                (15 min.)
New Marketing Applications/Resubmissions (NDA/BLA)....  ................             157               1             157            0.75             118
                                                                                (45 min.)
Clinical Amendments to Marketing Applications.........  ................           1,466               1           1,466            0.75           1,100
                                                                                (45 min.)
Efficacy Supplements/Resubmissions....................  ................             166               1             166            0.75             125
                                                                                (45 min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................................              281   ..............               1             281            0.25              70
                                                                                (15 min.)
Clinical Protocol Amendments (IND)....................            1,471   ..............               1           1,471            0.25             368
                                                                                (15 min.)
New Marketing Applications/Resubmissions..............  ................               8               1               8            0.75               6
                                                                                (45 min.)
Clinical Amendments to Marketing Applications.........  ................              17               1              17            0.75              13
                                                                                (45 min.)
Efficacy Supplements/Resubmissions (BLA only).........  ................              25               1              25            0.75              19
                                                                                (45 min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications (includes PMAs, HDEs,        ................             892               1             892            0.75             669
 Supplements and 510(k)s expected to contain clinical                                                                          (45 min.)
 data)................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications.................................  ................             854               1             854            0.75             641
                                                                                (45 min.)
BE Supplements/Amendments.............................  ................             495  ..............  ..............            0.75             372
                                                                                (45 min.)
    Total.............................................  ................  ..............  ..............  ..............  ..............          6,882
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24581 Filed 9-23-11; 8:45 am]
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[Federal Register: October 29, 2007 (Volume 72, Number 208)]
[Notices]
[Page 61201-61202]
[DOCID:fr29oc07-108]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Information

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) approval of a new
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on July 3, 2007, vol. 72, no. 127, page
36542-36543. The FAA issues Special Airworthiness Information Bulletins
(SAIBs to alert, educate, and make recommendations to the aviation
community and individual aircraft owners and operators about ways to
improve the safety of a product.

DATES: Please submit comments by November 28, 2007.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Reporting of Information Using Special Airworthiness
Information Bulletins.
    Type of Request: Approval of a new collection.
    OMB Control Number: 2120-XXXX.
    Form(s): There are no FAA forms associated with this collection.
    Affected Public: An estimated 1,120 respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 5 minutes per
response.
    Estimated Annual Burden Hours: An estimated 933 hour annually.
    Abstract: The FAA issues Special Airworthiness Information
Bulletins (SAIBs) to alert, educate, and make recommendations to the
aviation community and individual aircraft owners and operators about
ways to improve the safety of a product. It contains non-regulatory
information and guidance that is advisory; recommended actions or
inspections; and may include a request for voluntary reporting of
results from those actions/inspections. This reported information is
used to help the FAA assess whether a potential unsafe condition
warrants issuance of an airworthiness directive (AD).

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to Nathan Lesser, Desk Officer, Department of Transportation/
FAA, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on October 23, 2007.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 07-5362 Filed 10-26-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Rules and Regulations]
[Pages 59139-59140]
[FR Doc No: 2014-23435]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

Driver Qualifications; Regulatory Guidance Concerning the
Applicability of Language Requirement to Drivers Who Do Not Meet the
Hearing Standard

AGENCY: Federal Motor Carrier Safety Administration, DOT.

ACTION: Notice of regulatory guidance.

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

SUMMARY: The FMCSA provides regulatory guidance concerning the
applicability of the driver qualification requirement that interstate
drivers must be able to read and speak the English language
sufficiently to converse with the general public and respond to
official inquiries to drivers who do not meet the Agency's hearing
standard. The guidance explains that the English-language rule should
not be construed to prohibit operation of a commercial motor vehicle
(CMV) by hearing impaired drivers who can read and write in the English
language but do not speak, for whatever reason. While the Federal Motor
Carrier Safety Regulations (FMCSRs) prohibit individuals who do not
meet the hearing standard from operating CMVs in interstate commerce,
FMCSA has granted exemptions to a number of hearing-impaired
individuals. Some hearing impaired drivers have advised the National
Association of the Deaf that they have been told by State licensing
agency officials that they do not meet the English language requirement
essentially because they do not speak. This guidance is intended to
address the perceived conflict between the exemptions and the manner in
which FMCSA regulations are being applied to hearing impaired drivers.

DATES: This guidance is effective October 1, 2014.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas L. Yager, Chief, Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations; 1200 New Jersey Ave. SE., Washington, DC 20590, Telephone
202-366-4325, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Legal Basis

    The Secretary of Transportation has statutory authority to set
minimum standards for commercial motor vehicle safety. These minimum
standards must ensure that: (1) CMVs are maintained, equipped, loaded,
and operated safely; (2) the responsibilities imposed on operators of
CMVs do not impair their ability to operate the vehicles safely; (3)
the physical condition of operators of CMVs is adequate to enable them
to operate the vehicles safely; (4) the operation of CMVs does not have
a deleterious effect on the physical condition of the operators; and
(5) an operator of a CMV is not coerced by a motor carrier, shipper,
receiver, or transportation intermediary to operate a commercial motor
vehicle in violation of a regulation. (49 U.S.C. 31136(a)(1)-(5), as
amended). The Secretary also has broad power in carrying out motor
carrier safety statutes and regulations to ``prescribe recordkeeping
and reporting requirements'' and to ``perform other acts the Secretary
considers appropriate.'' (49 U.S.C. 31133(a)(8) and (10)).
    The Administrator of FMCSA has been delegated authority under 49
CFR 1.87(f) to carry out the functions vested in the Secretary of
Transportation by 49 U.S.C. chapter 311, subchapters I and III,
relating to commercial motor vehicle programs and safety regulation.

Background

History of the English Language Requirement

    On December 23, 1936, as part of its newly-promulgated ``Motor
Carrier Safety Regulations,'' the Interstate Commerce Commission (ICC)
established an English language requirement for drivers of motor
vehicles operated in interstate or foreign commerce by common and
contract carriers. The original wording, as contained in paragraph 3 of
Part I [Qualification of Drivers] required that:

    On and after July 1, 1937, no motor carrier shall drive, or
require or permit any person to drive, any motor vehicle operated in
interstate or foreign commerce, unless the person so driving
possesses the following minimum qualifications: * * * (k) Ability to
read and speak the English language, unless the person was engaged
in so driving on July 1, 1937 or within one year prior thereto, but
in any case ability to understand traffic and warning signs. (1
M.C.C. 1, at 18-19)

The preamble to the I.C.C decision stated that:

    It is evident that ability to read and speak English is
important to any adequate compliance with safety regulations.
Cognizance has been taken, however, of the existence in certain
areas of numbers of drivers in present service who are unable to
read or speak English, but even in these cases the ability at least
to understand traffic and warning signs is required. (1 M.C.C. 1, at
7-8)

    On May 27, 1939, the ICC made certain changes and additions to the
Motor Carrier Safety Regulations,

including elimination of the exceptions granted by the original rules
for those drivers unable to read and speak English. As stated in that
notice,

    ``The intent of the Commission to require such ability of all
drivers in this service has been unmistakable since 1937, and the
intervening period of more than two years is regarded as sufficient
to justify the removal of the exception.'' (14 M.C.C. 669, at 675)

    Section 391.11(b)(2) of the Federal Motor Carrier Safety
Regulations (FMCSRs) currently states that a person is qualified to
drive a commercial motor vehicle if he/she ``can read and speak the
English language sufficiently to converse with the general public, to
understand highway traffic signs and signals in the English language,
to respond to official inquiries, and to make entries on reports and
records.''

Relationship Between the English Language Rule and the Hearing Standard

    Currently, FMCSA's physical qualifications standards under 49 CFR
391.41(b)(11) require that drivers be capable of hearing a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid.

Section 391.41(b)(11) Exemptions

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the safety regulations for a 2-year period if it finds ``such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption.'' The statute also allows the Agency to renew exemptions at
the end of the 2-year period.
    On February 1, 2013, FMCSA announced its decision to grant requests
from 40 individuals for exemptions from the Agency's physical
qualifications standard concerning hearing for interstate drivers (78
FR 7479). After notice and opportunity for public comment, the Agency
concluded that granting exemptions for these CMV drivers will provide a
level of safety that is equivalent to or greater than the level of
safety maintained without the exemptions. As part of the process for
reaching this decision, the Agency considered the medical status of
each applicant and evaluated their crash and violation data; some of
the applicants were driving CMVs in intrastate commerce. The Commercial
Driver's License Information System and Motor Carrier Management
Information System were searched for crash and violation data on the
applicants and each of them demonstrated a safe driving history. The
FMCSA granted exemptions that allow these 40 individuals to operate
CMVs in interstate commerce for a 2-year period. Subsequently, FMCSA
granted an additional 20 exemptions and requested public comment on
more than 70 applications for exemptions from the hearing standard. The
exemptions preempt State laws and regulations and may be renewed by
FMCSA.
    Following the decision to grant exemptions, because some hearing-
impaired drivers granted exemptions do not speak English, it has been
asserted that they may not meet the requirements of Sec.  391.11(b)(2)
and may not be qualified to operate CMVs in interstate commerce, even
though they can read and write in English. This issue was first raised
by the National Association of the Deaf in discussions with the Agency
prior to the granting of the exemptions and continues to be an issue in
need of clarification.

FMCSA's Decision To Issue Regulatory Guidance

    In consideration of the above, FMCSA has determined that regulatory
guidance should be issued to make clear that, for drivers exempted from
the hearing standard in 49 CFR 391.41(b)(11) who cannot speak English,
the ability to read and write in English is sufficient to satisfy the
English-language requirement of 49 CFR 391.11(b)(2). The FMCSA adds
Question 7 to its guidance for 49 CFR 391.11, to read as follows:

Qualification and Disqualification of Drivers; Regulatory Guidance for
49 CFR 391.11(b)(2)

    Question 7: Would a driver who fails to meet the hearing standard
under 49 CFR 391.41(b)(11) but has obtained an exemption from that
requirement, be considered unqualified under the English language
proficiency requirement in 49 CFR 391.11(b)(2) if the driver cannot
communicate orally in English?
    Guidance: No, if the hearing impaired driver with an exemption is
capable of reading and writing in the English language. In that
circumstance, the hearing impaired driver satisfies the English
language requirement. The absence of an ability to speak in English is
not an indication that the individual cannot read and write in English
sufficiently to communicate with the general public, to understand
highway traffic signs and signals in the English language, to respond
to official inquiries, and to make entries on reports and records.

    Issued on: September 25, 2014.
T. F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2014-23435 Filed 9-30-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22495-22496]
[FR Doc No: 2018-10281]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-N-4951; FDA-2017-N-5569; FDA-2017-N-6145; FDA-
2011-N-0275; FDA-2017-N-7012; and FDA-2017-N-6175]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. 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 OMB control number.

        Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                number          expires
------------------------------------------------------------------------
Medical Devices; Humanitarian Use              0910-0332       3/31/2021
 Devices................................
Medical Devices; Device Tracking........       0910-0442       3/31/2021
Dispute Resolution Procedures for              0910-0566       3/31/2021
 Science-Based Decisions on Products
 Regulated by the Center for Veterinary
 Medicine...............................
Certification to Accompany Drug,               0910-0616       3/31/2021
 Biological Product, and Device
 Applications or Submissions (Form FDA
 3674)..................................
Use of Public Human Genetic Variant            0910-0850       3/31/2021
 Databases to Support Clinical Validity
 for Genetic and Genomic-Based In Vitro
 Diagnostics............................

Food and Drug Administration Recall            0910-0249       4/30/2021
 Regulations............................
------------------------------------------------------------------------

    Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10281 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P