[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Rules and Regulations]
[Pages 46187-46190]
[FR Doc No: 2014-18637]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-8343]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained

from FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
Part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

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                                                 Effective date
                                                 authorization/
                                   Community    cancellation of   Current effective  map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
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           Region IV

Alabama:
     Ashford, City of, Houston         010099  July 15,1975,      Sept. 3, 2014.........  Sept. 3, 2014.
     County.                                    Emerg; September
                                                4, 1985, Reg;
                                                September 3,
                                                2014, Susp.
    Autauga County,                    010314  December 16,       ......*do.............   do.
     Unincorporated Areas.                      1975, Emerg;
                                                December 18,
                                                1985, Reg;
                                                September 3,
                                                2014, Susp.
    Autaugaville, Town of,             010001  February 3, 1986,  ......do..............   do.
     Autauga County.                            Emerg; February
                                                3, 1986, Reg;
                                                September 3,
                                                2014, Susp.
    Avon, Town of, Houston             010100  December 30,       ......do..............   do.
     County.                                    1975, Emerg;
                                                September 1,
                                                1986, Reg;
                                                September 3,
                                                2014, Susp.
    Benton, Town of, Lowndes           015002  February 25,       ......do..............   do.
     County.                                    1972, Emerg;
                                                April 6, 1973,
                                                Reg; September
                                                3, 2014, Susp.

    Columbia, Town of, Houston         010101  December 9, 1977,  ......do..............   do.
     County.                                    Emerg; September
                                                4, 1985, Reg;
                                                September 3,
                                                2014, Susp.
    Coosada, Town of, Elmore           015012  September 17,      ......do..............   do.
     County.                                    1986, Emerg;
                                                September 17,
                                                1986, Reg;
                                                September 3,
                                                2014, Susp.
    Cottonwood, Town of,               010102  December 24,       ......do..............   do.
     Houston County.                            1975, Emerg;
                                                April 5, 1988,
                                                Reg; September
                                                3, 2014, Susp.
    Cowarts, Town of, Houston          010103  October 29, 1998,  ......do..............   do.
     County.                                    Emerg; December
                                                16, 2005, Reg;
                                                September 3,
                                                2014, Susp.
    Dallas County,                     010063  April 11, 1975,    ......do..............   do.
     Unincorporated Areas.                      Emerg; September
                                                29, 1986, Reg;
                                                September 3,
                                                2014, Susp.
    Dothan, City of, Dale and          010104  February 21,       ......do..............   do.
     Houston Counties.                          1975, Emerg;
                                                January 15,
                                                1988, Reg;
                                                September 3,
                                                2014, Susp.
    Elmore, Town of, Elmore            010490  N/A, Emerg;        ......do..............   do.
     County.                                    January 12,
                                                2012, Reg;
                                                September 3,
                                                2014, Susp.
    Elmore County,                     010406  January 16, 1980,  ......do..............   do.
     Unincorporated Areas.                      Emerg; February
                                                19, 1986, Reg;
                                                September 3,
                                                2014, Susp.
    Gordon, Town of, Houston           010105  January 19, 1976,  ......do..............   do.
     County.                                    Emerg; April 2,
                                                1986, Reg;
                                                September 3,
                                                2014, Susp.
    Houston County,                    010098  June 25, 1975,     ......do..............   do.
     Unincorporated Areas.                      Emerg; September
                                                29, 1989, Reg;
                                                September 3,
                                                2014, Susp.
    Kinsey, Town of, Houston           010106  September 3,       ......do..............   do.
     County.                                    1975, Emerg;
                                                September 29,
                                                1986, Reg;
                                                September 3,
                                                2014, Susp.
    Lowndes County,                    010272  December 11,       ......do..............   do.
     Unincorporated Areas.                      1975, Emerg;
                                                August 15, 1984,
                                                Reg; September
                                                3, 2014, Susp.
    Madrid, Town of, Houston           010107  November 6, 1975,  ......do..............   do.
     County.                                    Emerg; July 18,
                                                1985, Reg;
                                                September 3,
                                                2014, Susp.
    Millbrook, City of, Autauga        010370  October 18, 1979,  ......do..............   do.
     and Elmore Counties.                       Emerg; August
                                                15, 1984, Reg;
                                                September 3,
                                                2014, Susp.
    Prattville, City of,               010002  June 18, 1974,     ......do..............   do.
     Autauga and Elmore                         Emerg; August
     Counties.                                  15, 1978, Reg;
                                                September 3,
                                                2014, Susp.
    Rehobeth, Town of, Houston         010392  N/A, Emerg; July   ......do..............   do.
     County.                                    17, 2003, Reg;
                                                September 3,
                                                2014, Susp.
    Selma, City of, Dallas             010065  May 7, 1974,       ......do..............   do.
     County.                                    Emerg; March 4,
                                                1986, Reg;
                                                September 3,
                                                2014, Susp.
    Taylor, Town of, Houston           010108  N/A, Emerg; April  ......do..............   do.
     County.                                    15, 2004, Reg;
                                                September 3,
                                                2014, Susp.
    Valley Grande, City of,            010312  N/A, Emerg; June   ......do..............   do.
     Dallas County.                             8, 2004, Reg;
                                                September 3,
                                                2014, Susp.
    Wetumpka, City of, Elmore          010070  March 11, 1975,    ......do..............   do.
     County.                                    Emerg; January
                                                3, 1986, Reg;
                                                September 3,
                                                2014, Susp.
    White Hall, Town of,               010507  N/A, Emerg;        ......do..............   do.
     Lowndes County.                            September 9,
                                                2010, Reg;
                                                September 3,
                                                2014, Susp.
            Region V

Indiana:
    Cass County, Unincorporated        180022  June 12, 1975,     ......do..............   do.
     Areas.                                     Emerg; August 3,
                                                1981, Reg;
                                                September 3,
                                                2014, Susp.
    Galveston, Town of, Cass           180356  April 12, 1976,    ......do..............   do.
     County.                                    Emerg; November
                                                8, 1978, Reg;
                                                September 3,
                                                2014, Susp.
    Logansport, City of, Cass          180023  May 1, 1975,       ......do..............   do.
     County.                                    Emerg; July 16,
                                                1981, Reg;
                                                September 3,
                                                2014, Susp.
    Walton, Town of, Cass              180024  July 31, 1975,     ......do..............   do.
     County.                                    Emerg; November
                                                8, 1978, Reg;
                                                September 3,
                                                2014, Susp.
    Wisconsin: Delavan, City           550463  October 18, 1974,  ......do..............   do.
     of, Walworth County.                       Emerg; September
                                                1, 1983, Reg;
                                                September 3,
                                                2014, Susp.
    Fontana on Geneva Lake,            550592  N/A, Emerg; March  ......do..............   do.
     Village of, Walworth                       23, 2006, Reg;
     County.                                    September 3,
                                                2014, Susp.
    Walworth County,                   550462  June 10, 1975,     ......do..............   do.
     Unincorporated Areas.                      Emerg; August
                                                15, 1983, Reg;
                                                September 3,
                                                2014, Susp.
    Whitewater, City of,               550200  March 27, 1975,    ......do..............   do.
     Jefferson and Walworth                     Emerg; June 1,
     Counties.                                  1982, Reg;
                                                September 3,
                                                2014, Susp.
           Region VI

Texas:
    Clarksville City, City of,         480535  N/A, Emerg; April  ......do..............   do.
     Gregg and Upshur Counties.                 9, 2009, Reg;
                                                September 3,
                                                2014, Susp.
    Easton, City of, Gregg and         481145  December 7, 1988,  ......do..............   do.
     Rusk Counties.                             Emerg; December
                                                1, 1989, Reg;
                                                September 3,
                                                2014, Susp.
    Gladewater, City of, Gregg         480262  November 1, 1974,  ......do..............   do.
     and Upshur Counties.                       Emerg; January
                                                16, 1981, Reg;
                                                September 3,
                                                2014, Susp.
    Gregg County,                      480261  March 3, 1981,     ......do..............   do.
     Unincorporated Areas.                      Emerg; January
                                                3, 1990, Reg;
                                                September 3,
                                                2014, Susp.

    Harrison County,                   480847  March 18, 1988,    ......do..............   do.
     Unincorporated Areas.                      Emerg; November
                                                1, 1989, Reg;
                                                September 3,
                                                2014, Susp.
    Longview, City of, Gregg           480264  December 6, 1973,  ......do..............   do.
     and Harrison Counties.                     Emerg; December
                                                15, 1977, Reg;
                                                September 3,
                                                2014, Susp.
    Marshall, City of, Harrison        480319  July 17, 1974,     ......do..............   do.
     County.                                    Emerg; September
                                                16, 1981, Reg;
                                                September 3,
                                                2014, Susp.
    Uncertain, City of,                481559  August 21, 1979,   ......do..............   do.
     Harrison County.                           Emerg; August
                                                21, 1979, Reg;
                                                September 3,
                                                2014, Susp.
    Warren City, City of, Gregg        480840  April 13, 1981,    ......do..............   do.
     and Upshur Counties.                       Emerg; July 3,
                                                1985, Reg;
                                                September 3,
                                                2014, Susp.
    White Oak, City of, Gregg          480841  July 7, 1989,      ......do..............   do.
     County.                                    Emerg; December
                                                1, 1989, Reg;
                                                September 3,
                                                2014, Susp.
           Region VII

Kansas: Atchison, City of,             200010  February 7, 1975,  ......do..............   do.
 Atchison County.                               Emerg; June 1,
                                                1978, Reg;
                                                September 3,
                                                2014, Susp.
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*......do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: July 24, 2014.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2014-18637 Filed 8-6-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1554-1559]
[FR Doc No: 2015-00213]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73994; File No. SR-NYSE-2014-77]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending the Fees for NYSE Order Imbalances

January 6, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 23, 2014, the New York Stock Exchange LLC (``NYSE'' or
the ``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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the fees for NYSE Order Imbalances
to: (1)

Establish eligibility requirements for redistribution on a managed non-
display basis and an access fee for managed non-display data
recipients, and (2) make a non-substantive correction to the NYSE
Proprietary Market Data Fee Schedule (``Fee Schedule''), operative on
January 1, 2015. The text of the proposed rule change is available on
the Exchange's Web site at www.nyse.com, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to (1) amend the fees for NYSE Order
Imbalances to establish eligibility requirements for redistribution on
a managed non-display basis and to establish an access fee for managed
non-display data recipients of NYSE Order Imbalances, and (2) make a
non-substantive correction to the Fee Schedule, operative on January 1,
2015.
    Non-Display Use of NYSE market data means accessing, processing, or
consuming NYSE market data delivered via direct and/or Redistributor
\3\ data feeds for a purpose other than in support of a data
recipient's display or further internal or external redistribution. A
Redistributor approved for Managed Non-Display Services manages and
controls the access to NYSE Order Imbalances and does not allow for
further internal distribution or external redistribution of NYSE Order
Imbalances by the data recipients. Managed Non-Display Services Fees
apply when a data recipient's non-display applications are hosted by a
Redistributor that has been approved for Managed Non-Display Services.
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    \3\ ``Redistributor'' means a vendor or any other person that
provides an NYSE data product to a data recipient or to any system
that a data recipient uses, irrespective of the means of
transmission or access.
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    A Redistributor approved for Managed Non-Display Services is
required to report to the Exchange on a monthly basis the data
recipients that are receiving NYSE Order Imbalances through the
Redistributor's Managed Non-Display Service. A data recipient receiving
NYSE Order Imbalances through a Redistributor's Managed Non-Display
Service does not have any reporting requirements.
    Currently, to be approved for Managed Non-Display Services, a
Redistributor of the Managed Non-Display Services must be approved
under the Exchange's Unit-of-Count policy.\4\ The Exchange is proposing
to retire the Unit-of-Count Policy,\5\ and as a result, eligibility for
Managed Non-Display Services of NYSE Order Imbalances would no longer
be based on eligibility under the Unit-of-Count Policy. The Exchange
proposes instead to establish eligibility requirements specifically for
the redistribution of market data for Managed Non-Display Services. The
Exchange also proposes to add an access fee that would apply to a data
recipient that receives NYSE Order Imbalances from an approved
Redistributor of Managed Non-Display Services.
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    \4\ See Securities Exchange Act Release Nos. 59544 (Mar. 9,
2009), 74 FR 11162 (Mar. 16, 2009) (SR-NYSE-2008-131) and 62038 (May
5, 2010), 75 FR 26825 (May 12, 2010) (SR-NYSE-2010-22) (``Unit-of-
Count Policy filings''). See also Securities Exchange Act Release
No. 2014-43 (Aug. 26, 2014), 79 FR 52079 (Sept. 2, 2014) (NYSE 2014-
43) (establishing fees for non-display use of NYSE Order
Imbalances). The Unit-of-Count Policy currently applies to NYSE
OpenBook, NYSE Trades and NYSE BBO as a method for counting Users.
For NYSE Order Imbalances, the Policy sets the criteria for
eligibility for Managed Non-Display Services.
    \5\ The Exchange has separately proposed to retire the Unit-of-
Count Policy and modify the eligibility requirements for Managed
Non-Display Services for all of its proprietary market data
products, including NYSE Order Imbalances, and thereby harmonize the
eligibility requirements for all NYSE data products that have
Managed Non-Display fees. See SR-NYSE-2014-76 (amending fees for
NYSE OpenBook) and SR-NYSE-2014-75 (amending fees for NYSE BBO and
Trades) (collectively, ``NYSE 2014 Filings'').
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    The proposed eligibility requirements for the provision of Managed
Non-Display Services would be similar to the eligibility requirements
for the Unit-of-Count Policy in that they would require the
Redistributor to manage and control the access to NYSE Order Imbalances
for data recipients' non-display applications and not allow for further
internal distribution or external redistribution of the information by
data recipients. In addition, to be eligible to provide Managed Non-
Display Services, the Redistributor would be required to (a) host the
data recipients' non-display applications in equipment located in the
Redistributor's data center and/or hosted space/cage and (b) offer NYSE
Order Imbalances in the Redistributor's own messaging formats (rather
than using raw NYSE message formats) by reformatting and/or altering
NYSE Order Imbalances prior to retransmission without affecting the
integrity of NYSE Order Imbalances and without rendering NYSE Order
Imbalances inaccurate, unfair, uninformative, fictitious, misleading or
discriminatory. The proposed eligibility requirements are similar to
data distribution models currently in use and align the Exchange with
other markets.\6\
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    \6\ See Securities Exchange Act Release Nos. 70748 (Oct. 23,
2013), 70748 (Oct. 23, 2013), 78 FR 64569 (Oct. 29, 2013) (SR-Phlx-
2013-105) (notice of filing and immediate effectiveness of proposed
rule change to establish non-display Managed Data Solution for
NASDAQ OMX PHLX (``Phlx'')); 70269 (Aug. 27, 2013), 78 FR 54336
(Sept. 3, 2013) (SR-NASDAQ-2013-106) (notice of filing and immediate
effectiveness of proposed rule change to establish non-display
Managed Data Solution for the NASDAQ Stock Market (``NASDAQ'')); and
69182 (Mar. 19, 2013), 78 FR 18378 (Mar. 26, 2013) (SR-Phlx-2013-28)
(notice of filing and immediate effectiveness of proposed rule
change to establish non-display Managed Data Solution for Phlx
equities market PSX).
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    The reporting requirements associated with the Managed Non-Display
Service would not change. A Redistributor approved for Managed Non-
Display Service would be required to report to NYSE on a monthly basis
the data recipients that are receiving NYSE Order Imbalances through
the Redistributor's Managed Non-Display Service. A data recipient
receiving NYSE Order Imbalances through a Redistributor's Managed Non-
Display Service would continue not to have any reporting requirements.
    In addition, the Exchange proposes to adopt an Access Fee of $250/
month applicable only to data recipients that receive NYSE Order
Imbalances from an approved Redistributor of Managed Non-Display
Services, operative January 1, 2015. Currently, all data recipients,
including recipients of Managed Non-Display Services, are required to
pay an Access Fee of $500/month to receive NYSE Order Imbalances.
Because the purpose of an access fee is to charge data recipients for
access to the Exchange's proprietary market data, the Exchange believes
it is appropriate to charge an access fee to all data recipients.\7\ In
recognition that data

recipients of Managed Non-Display Services receive NYSE Order
Imbalances in a controlled format, the Exchange proposes to reduce the
Access Fee by half for those data recipients that only receive Managed
Non-Display Services for NYSE Order Imbalances. In connection with this
change, the Exchange also proposes to amend the Fee Schedule to specify
that the current Access Fee of $500/month is charged to data recipients
other than those receiving data through Managed Non-Display Services.
The proposed Managed Non-Display Access Fee would be in addition to the
current Managed Non-Display Services Fee of $200/month by each data
recipient.
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    \7\ In order to harmonize its approach to fees for its market
data products, the Exchange is proposing to establish access fees
for Managed Non-Display Services for NYSE OpenBook, NYSE BBO, and
NYSE Trades that is also half of the existing access fee for each
respective data feed. See NYSE 2014 Filings, supra note 5.
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    The Exchange also proposes to make a non-substantive amendment to
the Fee Schedule to add the word ``month'' to the Category 3 Non-
Display Fee, consistent with the other fees in the Fee Schedule.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\8\ in general, and
Sections 6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it
provides an equitable allocation of reasonable fees among users and
recipients of the data and is not designed to permit unfair
discrimination among customers, issuers, and brokers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4), (5).
---------------------------------------------------------------------------

    The Exchange believes that revising the eligibility requirements
for Managed Non-Display Services so that the requirements are more
closely aligned with the nature of the services being provided is
reasonable. The proposed additional requirements for hosting in the
Redistributor's data center and for reformatting and/or altering the
market data prior to retransmission are also consistent with similar
requirements of other markets for the provision of managed data.\10\
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    \10\ See supra note 6.
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    The Exchange believes that the proposed Access Fee for Managed Non-
Display Services is reasonable, because the data is of value to
recipients, and it is reasonable to charge them a lower access fee
because they are receiving the data through a Redistributor in a
controlled form rather than from the Exchange in raw form. The Exchange
believes that the proposed fee directly and appropriately reflects the
significant value of using non-display data in a wide range of
computer-automated functions relating to both trading and non-trading
activities and that the number and range of these functions continue to
grow through innovation and technology developments. The NASDAQ and
Phlx also both offer managed non-display data solutions and charge
access fees for such services.\11\ The fee is also equitable and not
unfairly discriminatory because it would apply to all data recipients
that choose to subscribe to Managed Non-Display Services for NYSE Order
Imbalances.
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    \11\ See supra note 6. NASDAQ offers a Managed Data Solution
that assesses a monthly Managed Data Solution Administration fee of
$1,500 and monthly Subscriber fees of $60 for non-professionals to
$300 for professionals. See NASDAQ Rule 7026(b). Phlx charges a
monthly Managed Data Solution Administration fee of $2,000 and a
monthly Subscriber fee of $500. The monthly License fee is in
addition to the monthly Distributor fee of $3,500 (for external
usage), and the $500 monthly Subscriber fee is assessed for each
Subscriber of a Managed Data Solution. See Securities Exchange Act
Release No. 70748 (Oct. 23, 2013), 78 FR 64569 (Oct. 29, 2013) (SR-
Phlx-2013-105).
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    The fees are also equitable and not unfairly discriminatory because
they will apply to all data recipients that choose to subscribe to the
feeds.
    The Exchange notes that NYSE Order Imbalances is entirely optional.
The Exchange is not required to make NYSE Order Imbalances available or
to offer any specific pricing alternatives to any customers, nor is any
firm required to purchase NYSE Order Imbalances. Firms that do purchase
NYSE Order Imbalances do so for the primary goals of using it to
increase revenues, reduce expenses, and in some instances compete
directly with the Exchange (including for order flow); those firms are
able to determine for themselves whether NYSE Order Imbalances or any
other similar products are attractively priced or not.
    The Exchange notes that broker-dealers are not required to purchase
proprietary market data to comply with their best execution
obligations.\12\ Similarly, there is no requirement in Regulation NMS
or any other rule that proprietary data be utilized for order routing
decisions, and some broker-dealers and alternative trading systems
(``ATSs'') have chosen not to do so.\13\ Firms that do not wish to
purchase NYSE Order Imbalances at the new price can choose similar
alternative products \14\ or can choose to conduct their business
operations in ways that do not use NYSE Order Imbalances data.
---------------------------------------------------------------------------

    \12\ See In the Matter of the Application of Securities Industry
And Financial Markets Association For Review of Actions Taken by
Self-Regulatory Organizations, Release Nos. 34-72182; AP-3-15350;
AP-3-15351 (May 16, 2014).
    \13\ For example, Goldman Sachs Execution and Clearing, L.P. has
disclosed that it does not use proprietary market data in connection
with Sigma X, its ATS. See response to Question E3, available at
http://www.goldmansachs.com/media-relations/in-the-news/current/pdf-media/gsec-order-handling-practices-ats-specific.pdf. By way of
comparison, IEX has disclosed that it uses proprietary market data
feeds from all registered stock exchanges and the LavaFlow ECN. See
http://www.iextrading.com/about/.
    \14\ See NASDAQ Rule 7023 (Nasdaq Totalview and OpenView).
---------------------------------------------------------------------------

    The decision of the United States Court of Appeals for the District
of Columbia Circuit in NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir.
2010), upheld reliance by the Securities and Exchange Commission
(``Commission'') upon the existence of competitive market mechanisms to
set reasonable and equitably allocated fees for proprietary market
data:

    In fact, the legislative history indicates that the Congress
intended that the market system `evolve through the interplay of
competitive forces as unnecessary regulatory restrictions are
removed' and that the SEC wield its regulatory power `in those
situations where competition may not be sufficient,' such as in the
creation of a `consolidated transactional reporting system.'

Id. at 535 (quoting H.R. Rep. No. 94-229 at 92 (1975), as reprinted in
1975 U.S.C.C.A.N. 323). The court agreed with the Commission's
conclusion that ``Congress intended that `competitive forces should
dictate the services and practices that constitute the U.S. national
market system for trading equity securities.' '' \15\
---------------------------------------------------------------------------

    \15\ NetCoalition, 615 F.3d at 535.
---------------------------------------------------------------------------

    As explained below in the Exchange's Statement on Burden on
Competition, the Exchange believes that there is substantial evidence
of competition in the marketplace for proprietary market data and that
the Commission can rely upon such evidence in concluding that the fees
established in this filing are the product of competition and therefore
satisfy the relevant statutory standards.
    As the NetCoalition decision noted, the Commission is not required
to undertake a cost-of-service or ratemaking approach. The Exchange
believes that, even if it were possible as a matter of economic theory,
cost-based pricing for non-core market data would be so complicated
that it could not be done practically or offer any significant
benefits.\16\
---------------------------------------------------------------------------

    \16\ The Exchange believes that cost-based pricing would be
impractical because it would create enormous administrative burdens
for all parties, including the Commission, to cost-regulate a large
number of participants and standardize and analyze extraordinary
amounts of information, accounts, and reports. In addition, and as
described below, it is impossible to regulate market data prices in
isolation from prices charged by markets for other services that are
joint products. Cost-based rate regulation would also lead to
litigation and may distort incentives, including those to minimize
costs and to innovate, leading to further waste. Under cost-based
pricing, the Commission would be burdened with determining a fair
rate of return, and the industry could experience frequent rate
increases based on escalating expense levels. Even in industries
historically subject to utility regulation, cost-based ratemaking
has been discredited. As such, the Exchange believes that cost-based
ratemaking would be inappropriate for proprietary market data and
inconsistent with Congress's direction that the Commission use its
authority to foster the development of the national market system,
and that market forces will continue to provide appropriate pricing
discipline. See Appendix C to NYSE's comments to the Commission's
2000 Concept Release on the Regulation of Market Information Fees
and Revenues, which can be found on the Commission's Web site at
http://www.sec.gov/rules/concept/s72899/buck1.htm.

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

    For these reasons, the Exchange believes that the proposed fees are
reasonable, equitable, and not unfairly discriminatory.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. An exchange's ability to
price its proprietary market data feed products is constrained by
actual competition for the sale of proprietary market data products,
the joint product nature of exchange platforms, and the existence of
alternatives to the Exchange's proprietary data.
The Existence of Actual Competition
    The market for proprietary data products is currently competitive
and inherently contestable because there is fierce competition for the
inputs necessary for the creation of proprietary data and strict
pricing discipline for the proprietary products themselves. Numerous
exchanges compete with one another for listings and order flow and
sales of market data itself, providing ample opportunities for
entrepreneurs who wish to compete in any or all of those areas,
including producing and distributing their own market data. Proprietary
data products are produced and distributed by each individual exchange,
as well as other entities, in a vigorously competitive market. Indeed,
the U.S. Department of Justice (``DOJ'') (the primary antitrust
regulator) has expressly acknowledged the aggressive actual competition
among exchanges, including for the sale of proprietary market data. In
2011, the DOJ stated that exchanges ``compete head to head to offer
real-time equity data products. These data products include the best
bid and offer of every exchange and information on each equity trade,
including the last sale.'' \17\
---------------------------------------------------------------------------

    \17\ Press Release, U.S. Department of Justice, Assistant
Attorney General Christine Varney Holds Conference Call Regarding
NASDAQ OMX Group Inc. and IntercontinentalExchange Inc. Abandoning
Their Bid for NYSE Euronext (May 16, 2011), available at http://www.justice.gov/iso/opa/atr/speeches/2011/at-speech-110516.html; see
also Complaint in U.S. v. Deutsche Borse AG and NYSE Euronext, Case
No. 11-cv-2280 (D.C. Dist.) ] 24 (``NYSE and Direct Edge compete
head-to-head . . . in the provision of real-time proprietary equity
data products.'').
---------------------------------------------------------------------------

    Moreover, competitive markets for listings, order flow, executions,
and transaction reports provide pricing discipline for the inputs of
proprietary data products and therefore constrain markets from
overpricing proprietary market data. Broker-dealers send their order
flow and transaction reports to multiple venues, rather than providing
them all to a single venue, which in turn reinforces this competitive
constraint. As a 2010 Commission Concept Release noted, the ``current
market structure can be described as dispersed and complex'' with
``trading volume . . . dispersed among many highly automated trading
centers that compete for order flow in the same stocks'' and ``trading
centers offer[ing] a wide range of services that are designed to
attract different types of market participants with varying trading
needs.'' \18\ More recently, SEC Chair Mary Jo White has noted that
competition for order flow in exchange-listed equities is ``intense''
and divided among many trading venues, including exchanges, more than
40 alternative trading systems, and more than 250 broker-dealers.\19\
---------------------------------------------------------------------------

    \18\ Concept Release on Equity Market Structure, Securities
Exchange Act Release No. 61358 (Jan. 14, 2010), 75 FR 3594 (Jan. 21,
2010) (File No. S7-02-10). This Concept Release included data from
the third quarter of 2009 showing that no market center traded more
than 20% of the volume of listed stocks, further evidencing the
dispersal of and competition for trading activity. Id. at 3598. Data
available on ArcaVision show that from June 30, 2013 to June 30,
2014, no exchange traded more than 12% of the volume of listed
stocks by either trade or dollar volume, further evidencing the
continued dispersal of and fierce competition for trading activity.
See https://www.arcavision.com/Arcavision/arcalogin.jsp.
    \19\ Mary Jo White, Enhancing Our Equity Market Structure,
Sandler O'Neill & Partners, L.P. Global Exchange and Brokerage
Conference (June 5, 2014) (available on the Commission Web site),
citing Tuttle, Laura, 2014, ``OTC Trading: Description of Non-ATS
OTC Trading in National Market System Stocks,'' at 7-8.
---------------------------------------------------------------------------

    If an exchange succeeds in its competition for quotations, order
flow, and trade executions, then it earns trading revenues and
increases the value of its proprietary market data products because
they will contain greater quote and trade information. Conversely, if
an exchange is less successful in attracting quotes, order flow, and
trade executions, then its market data products may be less desirable
to customers using them in support of order routing and trading
decisions in light of the diminished content; data products offered by
competing venues may become correspondingly more attractive. Thus,
competition for quotations, order flow, and trade executions puts
significant pressure on an exchange to maintain both execution and data
fees at reasonable levels.
    In addition, in the case of products that are distributed through
market data vendors, such as Bloomberg and Thompson Reuters, the
vendors themselves provide additional price discipline for proprietary
data products because they control the primary means of access to
certain end users. These vendors impose price discipline based upon
their business models. For example, vendors that assess a surcharge on
data they sell are able to refuse to offer proprietary products that
their end users do not or will not purchase in sufficient numbers.
Vendors will not elect to make available NYSE Order Imbalances unless
their customers request it, and customers will not elect to pay the
proposed fees unless NYSE Order Imbalances can provide value by
sufficiently increasing revenues or reducing costs in the customer's
business in a manner that will offset the fees. All of these factors
operate as constraints on pricing proprietary data products.
Joint Product Nature of Exchange Platform
    Transaction execution and proprietary data products are
complementary in that market data is both an input and a byproduct of
the execution service. In fact, proprietary market data and trade
executions are a paradigmatic example of joint products with joint
costs. The decision of whether and on which platform to post an order
will depend on the attributes of the platforms where the order can be
posted, including the execution fees, data availability and quality,
and price and distribution of their data products. Without a platform
to post quotations, receive orders, and execute trades, exchange data
products would not exist.
    The costs of producing market data include not only the costs of
the data distribution infrastructure, but also the costs of designing,
maintaining, and operating the exchange's platform for posting quotes,
accepting orders, and executing transactions and the cost of regulating
the exchange to ensure its fair operation and maintain investor
confidence. The total return that a trading platform earns reflects the

revenues it receives from both products and the joint costs it incurs.
    Moreover, an exchange's broker-dealer customers generally view the
costs of transaction executions and market data as a unified cost of
doing business with the exchange. A broker-dealer will only choose to
direct orders to an exchange if the revenue from the transaction
exceeds its cost, including the cost of any market data that the
broker-dealer chooses to buy in support of its order routing and
trading decisions. If the costs of the transaction are not offset by
its value, then the broker-dealer may choose instead not to purchase
the product and trade away from that exchange. There is substantial
evidence of the strong correlation between order flow and market data
purchases. For example, in November 2014 more than 80% of the
transaction volume on each of NYSE, and the NYSE's affiliates, NYSE
Arca, Inc. (``NYSE Arca'') and NYSE MKT LLC (``NYSE MKT''), was
executed by market participants that purchased one or more proprietary
market data products (the 20 firms were not the same for each market).
A supra-competitive increase in the fees for either executions or
market data would create a risk of reducing an exchange's revenues from
both products.
    Other market participants have noted that proprietary market data
and trade executions are joint products of a joint platform and have
common costs.\20\ The Exchange agrees with and adopts those discussions
and the arguments therein. The Exchange also notes that the economics
literature confirms that there is no way to allocate common costs
between joint products that would shed any light on competitive or
efficient pricing.\21\
---------------------------------------------------------------------------

    \20\ See Securities Exchange Act Release No. 72153 (May 12,
2014), 79 FR 28575, 28578 n.15 (May 16, 2014) (SR-NASDAQ-2014-045)
(``[A]ll of the exchange's costs are incurred for the unified
purposes of attracting order flow, executing and/or routing orders,
and generating and selling data about market activity. The total
return that an exchange earns reflects the revenues it receives from
the joint products and the total costs of the joint products.'').
See also Securities Exchange Act Release No. 62907 (Sept. 14, 2010),
75 FR 57314, 57317 (Sept. 20, 2010) (SR-NASDAQ-2010-110), and
Securities Exchange Act Release No. 62908 (Sept. 14, 2010), 75 FR
57321, 57324 (Sept. 20, 2010) (SR-NASDAQ-2010-111).
    \21\ See generally Mark Hirschey, Fundamentals of Managerial
Economics, at 600 (2009) (``It is important to note, however, that
although it is possible to determine the separate marginal costs of
goods produced in variable proportions, it is impossible to
determine their individual average costs. This is because common
costs are expenses necessary for manufacture of a joint product.
Common costs of production--raw material and equipment costs,
management expenses, and other overhead--cannot be allocated to each
individual by-product on any economically sound basis. . . . Any
allocation of common costs is wrong and arbitrary.''). This is not
new economic theory. See, e.g., F. W. Taussig, ``A Contribution to
the Theory of Railway Rates,'' Quarterly Journal of Economics V(4)
438, 465 (July 1891) (``Yet, surely, the division is purely
arbitrary. These items of cost, in fact, are jointly incurred for
both sorts of traffic; and I cannot share the hope entertained by
the statistician of the Commission, Professor Henry C. Adams, that
we shall ever reach a mode of apportionment that will lead to
trustworthy results.'').
---------------------------------------------------------------------------

    Analyzing the cost of market data product production and
distribution in isolation from the cost of all of the inputs supporting
the creation of market data and market data products will inevitably
underestimate the cost of the data and data products because it is
impossible to obtain the data inputs to create market data products
without a fast, technologically robust, and well-regulated execution
system, and system and regulatory costs affect the price of both
obtaining the market data itself and creating and distributing market
data products. It would be equally misleading, however, to attribute
all of an exchange's costs to the market data portion of an exchange's
joint products. Rather, all of an exchange's costs are incurred for the
unified purposes of attracting order flow, executing and/or routing
orders, and generating and selling data about market activity. The
total return that an exchange earns reflects the revenues it receives
from the joint products and the total costs of the joint products.
    As noted above, the level of competition and contestability in the
market is evident in the numerous alternative venues that compete for
order flow, including 12 equities self-regulatory organization
(``SRO'') markets, as well as various forms of ATSs, including dark
pools and electronic communication networks (``ECNs''), and
internalizing broker-dealers. SRO markets compete to attract order flow
and produce transaction reports via trade executions, and two FINRA-
regulated Trade Reporting Facilities compete to attract transaction
reports from the non-SRO venues.\22\
---------------------------------------------------------------------------

    \22\ FINRA's Alternative Display Facility also receives over-
the-counter trade reports that it sends to CTA.
---------------------------------------------------------------------------

    Competition among trading platforms can be expected to constrain
the aggregate return that each platform earns from the sale of its
joint products, but different trading platforms may choose from a range
of possible, and equally reasonable, pricing strategies as the means of
recovering total costs. For example, some platforms may choose to pay
rebates to attract orders, charge relatively low prices for market data
products (or provide market data products free of charge), and charge
relatively high prices for accessing posted liquidity. Other platforms
may choose a strategy of paying lower rebates (or no rebates) to
attract orders, setting relatively high prices for market data
products, and setting relatively low prices for accessing posted
liquidity. For example, BATS and Direct Edge, which previously operated
as ATSs and obtained exchange status in 2008 and 2010, respectively,
have provided certain market data at no charge on their Web sites in
order to attract more order flow, and use revenue rebates from
resulting additional executions to maintain low execution charges for
their users.\23\ Similarly, LavaFlow ECN provides market data to its
subscribers at no charge.\24\ In this environment, there is no economic
basis for regulating maximum prices for one of the joint products in an
industry in which suppliers face competitive constraints with regard to
the joint offering.
---------------------------------------------------------------------------

    \23\ This is simply a securities market-specific example of the
well-established principle that in certain circumstances more sales
at lower margins can be more profitable than fewer sales at higher
margins; this example is additional evidence that market data is an
inherent part of a market's joint platform.
    \24\ See ``LavaFlow--ADF Migration,'' available at https://www.lavatrading.com/news/pdf/LavaFlow_ADF_Migration.pdf.
---------------------------------------------------------------------------

Existence of Alternatives
    The large number of SROs, ATSs, and internalizing broker-dealers
that currently produce proprietary data or are currently capable of
producing it provides further pricing discipline for proprietary data
products. Each SRO, ATS, and broker-dealer is currently permitted to
produce and sell proprietary data products, and many currently do or
have announced plans to do so, including but not limited to the
Exchange, NYSE MKT, NYSE Arca, NASDAQ OMX, BATS, and Direct Edge.
    The fact that proprietary data from ATSs, internalizing broker-
dealers, and vendors can bypass SROs is significant in two respects.
First, non-SROs can compete directly with SROs for the production and
sale of proprietary data products. By way of example, BATS and NYSE
Arca both published proprietary data on the Internet before registering
as exchanges. Second, because a single order or transaction report can
appear in an SRO proprietary product, a non-SRO proprietary product, or
both, the amount of data available via proprietary products is greater
in size than the actual number of orders and transaction reports that
exist in the marketplace. With respect to NYSE Order Imbalances,
similar products are available from competitors.\25\ Because market
data

users can find suitable substitutes for most proprietary market data
products, a market that overprices its market data products stands a
high risk that users may substitute another source of market data
information for its own.
---------------------------------------------------------------------------

    \25\ See supra note 14.
---------------------------------------------------------------------------

    Those competitive pressures imposed by available alternatives are
evident in the Exchange's proposed pricing, and indeed in the fact that
the changes here have the effect of lowering the price for NYSE Order
Imbalances.
    In addition to the competition and price discipline described
above, the market for proprietary data products is also highly
contestable because market entry is rapid and inexpensive. The history
of electronic trading is replete with examples of entrants that swiftly
grew into some of the largest electronic trading platforms and
proprietary data producers: Archipelago, Bloomberg Tradebook, Island,
RediBook, Attain, TrackECN, BATS Trading and Direct Edge. As noted
above, BATS launched as an ATS in 2006 and became an exchange in 2008,
while Direct Edge began operations in 2007 and obtained exchange status
in 2010. As noted above, LavaFlow ECN provides market data to its
subscribers at no charge.\26\
---------------------------------------------------------------------------

    \26\ See supra note 24.
---------------------------------------------------------------------------

    In setting the proposed fees, the Exchange considered the
competitiveness of the market for proprietary data and all of the
implications of that competition. The Exchange believes that it has
considered all relevant factors and has not considered irrelevant
factors in order to establish fair, reasonable, and not unreasonably
discriminatory fees and an equitable allocation of fees among all
users. The existence of numerous alternatives to the Exchange's
products, including proprietary data from other sources, ensures that
the Exchange cannot set unreasonable fees, or fees that are
unreasonably discriminatory, when vendors and subscribers can elect
these alternatives or choose not to purchase a specific proprietary
data product if the attendant fees are not justified by the returns
that any particular vendor or data recipient would achieve through the
purchase.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \27\ and paragraph (f)(2) of Rule 19b-4
thereunder.\28\ 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.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \28\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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_ADDRESS>Please include
File Number SR-NYSE-2014-77 on the subject line.

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-NYSE-2014-77. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of NYSE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2014-77 and should be
submitted on or before February 2, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-00213 Filed 1-9-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56976-56978]
[FR Doc No: 2017-25920]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6591]

Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 68 abbreviated new drug applications (ANDAs)
from multiple applicants. The holders of the applications notified the
Agency in writing that the drug products were no longer marketed and
requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 2, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040135...............  Estropipate Tablets    Barr Laboratories,
                             USP, 0.75 milligrams   Inc., Subsidiary of
                             (mg), 1.5 mg, and 3    Teva Pharmaceuticals
                             mg.                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 040755...............  Carisoprodol Tablets   Sun Pharmaceutical
                             USP, 350 mg.           Industries, Ltd., c/
                                                    o Sun Pharmaceutical
                                                    Industries, Inc.,
                                                    270 Prospect Plains
                                                    Rd., Cranbury, NJ
                                                    08512.

ANDA 062588...............  Gentamicin Sulfate in  Hospira, Inc., a
                             0.9% Sodium Chloride   Pfizer Company, 275
                             Injection,             North Field Dr.,
                             Equivalent to (EQ)     Bldg. H1, Lake
                             1.2 mg base/           Forest, IL 60045.
                             milliliter (mL), EQ
                             1.4 mg base/mL, EQ
                             1.6 mg base/mL, EQ
                             1.8 mg base/mL, EQ 2
                             mg base/mL, EQ 60 mg
                             base/100 mL, EQ 70
                             mg base/100 mL, EQ
                             80 mg base/100 mL,
                             EQ 90 mg base/100
                             mL, and EQ 100 mg
                             base/100 mL.
ANDA 062591...............  Kefurox (cefuroxime)   ACS Dobfar S.p.A., c/
                             for Injection USP,     o Interchem Corp.,
                             EQ 750 mg base/vial,   120 Route 17 North,
                             EQ 1.5 grams (g)       Paramus, NJ 07652.
                             base/vial, and EQ
                             7.5 g base/vial.
ANDA 062756...............  Primaxin IV (imipenem  Merck Sharp & Dohme
                             and cilastatin) for    Corp., Subsidiary of
                             Injection USP, 250     Merck & Co., Inc., 1
                             mg/vial; EQ 250 mg     Merck Dr., P.O. Box
                             base/vial and 500 mg/  100, Whitehouse
                             vial; EQ 500 mg base/  Station, NJ 08889.
                             vial.
ANDA 063207...............  Cefazolin for          Facta Farmaceutici
                             Injection USP, EQ 1    S.p.A., c/o
                             g base/vial.           Interchem Corp., 120
                                                    Route 17 North,
                                                    Suite 115, Paramus,
                                                    NJ 07652.
ANDA 063209...............  Cefazolin for          Do.
                             Injection USP, EQ 10
                             g base/vial and EQ
                             20 g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 063214...............  Cefazolin for          Do.
                             Injection USP, EQ
                             500 mg base/vial.
ANDA 063263...............  Amikacin Sulfate       Hospira, Inc.
                             Injection USP, EQ 50
                             mg base/mL.
ANDA 065268...............  Ceftriaxone for        Facta Farmaceutici
                             Injection USP, EQ 1    S.p.A.
                             g base/vial and EQ 2
                             g base/vial.
ANDA 065269...............  Ceftriaxone for        Do.
                             Injection USP, EQ 10
                             g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 065348...............  Cefotaxime for         Cephazone Pharma,
                             Injection USP, EQ 10   LLC, 250 E. Bonita
                             g base/vial            Ave., Pomona, CA
                             (Pharmacy Bulk         91767.
                             Package).
ANDA 065464...............  Cefoxitin for          ACS Dobfar S.p.A.
                             Injection USP, EQ 10
                             g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 065467...............  Cefoxitin for          Do.
                             Injection USP, EQ 1
                             g base/vial and EQ 2
                             g base/vial.
ANDA 070048...............  Cotrim D.S.            Teva Pharmaceuticals
                             (sulfamethoxazole      USA, Inc., 425
                             and trimethoprim)      Privet Rd., Horsham,
                             Tablets USP, 800 mg/   PA 19044.
                             160 mg.
ANDA 070195...............  Valproic Acid          Catalent Pharma
                             Capsules USP, 250 mg.  Solutions, LLC, 2725
                                                    Scherer Dr. North,
                                                    St. Petersburg, FL
                                                    33716.
ANDA 070513...............  Tolazamide Tablets     Watson Laboratories,
                             USP, 100 mg.           Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 070514...............  Tolazamide Tablets     Do.
                             USP, 250 mg.
ANDA 071358...............  Tolazamide Tablets     Sun Pharmaceutical
                             USP, 250 mg.           Industries, Inc.,
                                                    270 Prospect Plains
                                                    Rd., Cranbury, NJ
                                                    08512.
ANDA 071359...............  Tolazamide Tablets     Do.
                             USP, 500 mg.
ANDA 071667...............  Ibuprofen Tablets      Pliva, Inc.,
                             USP, 600 mg.           Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 071668...............  Ibuprofen Tablets      Do.
                             USP, 800 mg.
ANDA 071735...............  Ibuprofen Tablets      Contract Pharmacal
                             USP, 200 mg.           Corp., c/o SciRegs
                                                    International Inc.,
                                                    6333 Summercrest
                                                    Dr., Columbia, MD
                                                    21045.
ANDA 071773...............  Ibuprofen Tablets      Pliva, Inc.,
                             USP, 200 mg.           Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc.
ANDA 073254...............  Loperamide             Contract Pharmacal
                             Hydrochloride (HCl)    Corp.
                             Tablets USP, 2 mg.
ANDA 074075...............  Clemastine Fumarate    Actavis Mid Atlantic,
                             Syrup, EQ 0.5 mg       LLC, Subsidiary of
                             base/5 mL.             Teva Pharmaceuticals
                                                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 074536...............  Haloperidol Oral       Do.
                             Solution USP, EQ 1
                             mg base/mL.
ANDA 074782...............  Ibuprofen Capsules,    Contract Pharmacal
                             200 mg.                Corp.
ANDA 074789...............  Naproxen Sodium        Do.
                             Tablets USP, EQ 200
                             mg base.
ANDA 074931...............  Ibuprofen Tablets      Do.
                             USP, 200 mg.
ANDA 074961...............  Cimetidine Tablets     Do.
                             USP, 200 mg.
ANDA 074963...............  Cimetidine Tablets     Do.
                             USP, 200 mg.
ANDA 075094...............  Ranitidine Tablets     Do.
                             USP, EQ 75 mg base.
ANDA 075588...............  Ibuprofen and          Do.
                             Pseudoephedrine HCl
                             Tablets USP, 200 mg/
                             30 mg.
ANDA 077058...............  Pantoprazole Sodium    Sun Pharmaceutical
                             Delayed-Release        Industries, Ltd.
                             Tablets USP, EQ 20
                             mg base and EQ 40 mg
                             base.
ANDA 077172...............  Ondansetron Injection  Do.
                             USP, EQ 2 mg base/mL.
ANDA 077329...............  Octreotide Acetate     Do.
                             Injection, EQ 0.05
                             mg base/mL, EQ 0.1
                             mg base/mL, and EQ
                             0.5 mg base/mL.
ANDA 077330...............  Octreotide Acetate     Do.
                             Injection, EQ 0.2 mg
                             base/mL.
ANDA 077331...............  Octreotide Acetate     Do.
                             Injection, EQ 1 mg
                             base/mL.
ANDA 078108...............  Sertraline HCl         Do.
                             Tablets, EQ 25 mg
                             base, EQ 50 mg base,
                             and EQ 100 mg base.
ANDA 078478...............  Torsemide Tablets, 5   Do.
                             mg, 10 mg, 20 mg,
                             and 100 mg.
ANDA 083000...............  Folic Acid Tablets, 1  Ivax Pharmaceutical
                             mg.                    USA, Inc.,
                                                    Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 085549...............  Reserpine,             Watson Laboratories,
                             Hydralazine HCl, and   Inc., Subsidiary of
                             Hydrochlorothiazide    Teva Pharmaceuticals
                             Tablets, 0.1 mg/25     USA, Inc.
                             mg/15 mg.
ANDA 086109...............  Tolbutamide Tablets    Do.
                             USP, 500 mg.
ANDA 086577...............  Trimethobenzamide HCl  Do.
                             Injection, 100 mg/mL.

ANDA 087191...............  Triamcinolone          Alpharma U.S. Pharms,
                             Acetonide Lotion       Subsidiary of Teva
                             USP, 0.025%.           Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 087398...............  Spironolactone and     Watson Laboratories,
                             Hydrochlorothiazide    Inc., Subsidiary of
                             Tablets USP, 25 mg/    Teva Pharmaceuticals
                             25 mg.                 USA, Inc.
ANDA 088229...............  Thioridazine HCl Oral  Actavis Mid Atlantic,
                             Solution USP, 100 mg/  LLC, Subsidiary of
                             mL.                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 088563...............  Thioridazine HCl       Watson Laboratories,
                             Tablets USP, 50 mg.    Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 088567...............  Thioridazine HCl       Do.
                             Tablets USP, 25 mg.
ANDA 088733...............  Meclizine HCl          Pliva, Inc.,
                             Tablets, 25 mg         Subsidiary of Teva
                             (Chewable).            Pharmaceuticals USA,
                                                    Inc.
ANDA 088869...............  Thioridazine HCl       Watson Laboratories,
                             Tablets USP, 150 mg.   Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 090800...............  Quinapril Tablets      Sun Pharmaceutical
                             USP, EQ 5 mg base,     Industries, Ltd.
                             EQ 10 mg base, EQ 20
                             mg base, and EQ 40
                             mg base.
ANDA 091177...............  Anastrozole Tablets,   Do.
                             1 mg.
ANDA 091466...............  Letrozole Tablets      Do.
                             USP, 2.5 mg.
ANDA 200486...............  Norethindrone and      Mylan Laboratories,
                             Ethinyl Estradiol      Ltd., c/o Mylan
                             Tablets USP, 0.5 mg/   Pharmaceuticals,
                             0.035 mg, 0.75 mg/     Inc., 781 Chestnut
                             0.035 mg, and 1 mg/    Ridge Rd., P.O. Box
                             0.035 mg.              4310, Morgantown, WV
                                                    26504.
ANDA 200488...............  Norethindrone and      Do.
                             Ethinyl Estradiol
                             Tablets USP, 0.5 mg/
                             0.035 mg.
ANDA 200489...............  Norethindrone and      Do.
                             Ethinyl Estradiol
                             Tablets USP, 1 mg/
                             0.035 mg.
ANDA 201250...............  Vancomycin HCl for     Teva Pharmaceuticals
                             Injection USP, EQ 5    USA, Inc.
                             g base/vial and EQ
                             10 g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 201251...............  Vancomycin HCl for     Do.
                             Injection USP, EQ
                             500 mg base/vial and
                             EQ 1 g base/vial.
ANDA 201828...............  Norgestrel and         Mylan Laboratories,
                             Ethinyl Estradiol      Ltd.
                             Tablets USP, 0.3 mg/
                             0.03 mg.
ANDA 202203...............  Topotecan HCl for      Sun Pharmaceutical
                             Injection, EQ 4 mg     Industries, Ltd.
                             base/vial.
ANDA 202746...............  Zoledronic Acid        Sun Pharma Global
                             Injection, EQ 4 mg     FZE, c/o Sun
                             base/5 mL.             Pharmaceutical
                                                    Industries, Inc., 2
                                                    Independence Way,
                                                    Princeton, NJ 08540.
ANDA 202875...............  Norgestrel and         Mylan Laboratories,
                             Ethinyl Estradiol      Ltd.
                             Tablets USP, 0.5 mg/
                             0.05 mg.
ANDA 203476...............  Zolmitriptan Tablets,  Sun Pharma Global
                             2.5 mg and 5 mg.       FZE.
ANDA 203685...............  Irbesartan Tablets     Ajanta Pharma Ltd., c/
                             USP, 75 mg, 150 mg,    o Ajanta Pharma USA,
                             and 300 mg.            Inc., One Grande
                                                    Commons, 440 US
                                                    Highway 22 East,
                                                    Suite 150,
                                                    Bridgewater, NJ
                                                    08807.
ANDA 203838...............  Hydrocodone            Tris Pharma, Inc.,
                             Bitartrate,            2033 Route 130,
                             Chlorpheniramine       Monmouth Junction,
                             Maleate, and           NJ 08852.
                             Pseudoephedrine HCl
                             Oral Solution, 5 mg/
                             4 mg/60 mg per 5 mL.
ANDA 203839...............  Hydrocodone            Do.
                             Bitartrate and
                             Pseudoephedrine HCl
                             Oral Solution, 5 mg/
                             60 mg per 5 mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1 of this
document, and all amendments and supplements thereto, is hereby
withdrawn as of January 2, 2018. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that
are listed in table 1 that are in inventory on the date that this
notice becomes effective (see the DATES section) may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.

    Dated: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy..
[FR Doc. 2017-25920 Filed 11-30-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50144-50145]
[FR Doc No: 2017-23492]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

De Novo Classification Process (Evaluation of Automatic Class III
Designation); Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``De Novo Classification
Process (Evaluation of Automatic Class III Designation).'' The purpose
of this document is to provide guidance on the process for the
submission and review of a De Novo classification request (hereafter a
``De Novo request'') under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act), also known as the De Novo classification process. FDA
is issuing this guidance to also provide updated recommendations for
interactions with FDA related to the De Novo classification process,
including what information to submit when seeking a path to market via
the De Novo classification process. This guidance replaces ``New
Section 513(f)(2)--Evaluation of Automatic Class III Designation,
Guidance for Industry and CDRH Staff,'' dated February 19, 1998.

DATES: The announcement of the guidance is published in the Federal
Register on October 30, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0689 for ``De Novo Classification Process (Evaluation of
Automatic Class III Designation); Guidance for Industry and Food and
Drug Administration Staff; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled ``De
Novo Classification Process (Evaluation of Automatic Class III
Designation)'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002 or the Office of Communication, Outreach,
and Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,

Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sergio de del Castillo, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002,
301-796-6419; and Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 301-240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The automatic class III designation for devices of a new type
occurs by operation of law and without any action by FDA, regardless of
the level of risk posed. Any device that is of a new type that was not
in commercial distribution before May 28, 1976, is automatically
classified as, and remains within, class III and requires premarket
approval unless and until FDA takes an action to classify or reclassify
the device section 513(f)(1) of the FD&C Act (21 U.S.C. 360c(f)(1)). We
refer to these devices as ``postamendments devices'' because they were
not in commercial distribution prior to the date of enactment of the
Medical Device Amendments of 1976.
    FDA may classify a device through the De Novo classification
process, which is the pathway authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). A person may submit a De Novo request
after submitting a premarket notification under section 510(k) of the
FD&C Act and receiving a not substantially equivalent (NSE)
determination (section 513(f)(2)(A)(i) of the FD&C Act). A person may
also submit a De Novo request without first submitting a premarket
notification under section 510(k), if the person determines that there
is no legally marketed device upon which to base a determination of
substantial equivalence (section 513(f)(2)(A)(ii) of the FD&C Act).
    Upon receipt of a De Novo request, FDA is required to classify the
device by written order (section 513(f)(2)(A)(iii) of the FD&C Act).
The classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Per section
513(f)(2)(B)(i) of the FD&C Act, the classification is the initial
classification of the device for the purposes of section 513(f)(1) of
the FD&C Act.
    We believe De Novo classification will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens. When FDA
classifies a device into class I or II via the De Novo classification
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (section 513(f)(2)(B)(i)). As a result,
other device sponsors do not have to submit a De Novo request or PMA in
order to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when applicable, as a pathway
to market their device.
    FDA is issuing this document to provide guidance on the process for
the submission and review of a De Novo request under section 513(f)(2)
of the FD&C Act, also known as the De Novo classification process. This
guidance also provides updated recommendations for interactions with
FDA related to the De Novo classification process, including what
information to submit when seeking a path to market via the De Novo
classification process. This guidance will provide clarity regarding
the Agency's review process and expectations for information to be
submitted in a De Novo request and ensures predictability and
consistency for sponsors.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register (79 FR 47651) of August 14, 2014. FDA
revised the guidance as appropriate in response to the comments. This
document supersedes ``New Section 513(f)(2)--Evaluation of Automatic
Class III Designation, Guidance for Industry and CDRH Staff'' dated
February 19, 1998.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the De Novo Classification Process
(Evaluation of Automatic Class III Designation). It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1760 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the guidance ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844. The collections of
information in the guidance document ``Requests for Feedback on Medical
Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff'' have been approved under OMB control
number 0910-0756. The collections of information in 21 CFR part 807,
subpart E have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; and the collections of information in 21
CFR part 801 have been approved under OMB control number 0910-0485.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23492 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P