[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54132-54133]
[FR Doc No: 2018-23383]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2018-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The date of December 21, 2018 has been established for the FIRM
and, where applicable, the supporting FIS report showing the new or
modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

David I. Maurstad,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Alameda County, California and Incorporated Areas
                         Docket No.: FEMA-B-1532
------------------------------------------------------------------------
City of Alameda........................  City Hall West, 950 West Mall
                                          Square, Room 110, Alamada, CA
                                          94501.
City of Albany.........................  City Hall, 1000 San Pablo
                                          Avenue, Albany, CA 94706.
City of Berkeley.......................  Permit Service Center, 2120
                                          Milvia Street, Berkeley, CA
                                          94704.
City of Emeryville.....................  Engineering Department, 1333
                                          Park Avenue, Emeryville, CA
                                          94608.
City of Hayward........................  City Hall, 777 B Street,
                                          Hayward, CA 94541.
City of Oakland........................  Permit Center, 250 Frank H.
                                          Ogawa Plaza, Room 2114, 2nd
                                          Floor, Oakland, CA 94612.
City of San Leandro....................  Division of Building and
                                          Safety, 835 East 14th Street,
                                          San Leandro, CA 94577.
Unincorporated Areas of Alameda County.  Public Works Agency, 399
                                          Elmhurst Street, #113,
                                          Hayward, CA 94544.
------------------------------------------------------------------------
          Los Angeles County, California and Incorporated Areas
           Docket Nos.: FEMA-B-1553, FEMA-B-1664 & FEMA-B-1720
------------------------------------------------------------------------
City of Culver City....................  City Hall, 9770 Culver
                                          Boulevard, 2nd Floor, Culver
                                          City, CA 90232.
City of Los Angeles....................  Department of Public Works,
                                          1149 South Broadway, Suite
                                          810, Los Angeles, CA 90015.
Unincorporated Areas of Los Angeles      Los Angeles County Watershed
 County.                                  Management, 900 South Fremont
                                          Avenue, Alhambra, CA 91803.
------------------------------------------------------------------------
              Jasper County, Indiana and Incorporated Areas
                Docket Nos.: FEMA-B-1276 and FEMA-B-1648
------------------------------------------------------------------------
City of Rensselaer.....................  City Hall, Building Department,
                                          124 South Van Rensselaer
                                          Street, Rensselaer, IN 47978.
Town of DeMotte........................  Town Hall, 112 Carnation Street
                                          SE, DeMotte, IN 46310.
Town of Remington......................  Town Hall, 24 South Indiana
                                          Street, Remington, IN 47977.
Town of Wheatfield.....................  Town Hall, 170 South Grace
                                          Street, Wheatfield, IN 46392.

Unincorporated Areas of Jasper County..  Jasper County Planning and
                                          Development, Jasper County
                                          Courthouse, 115 West
                                          Washington Street, Suite 109,
                                          Rensselaer, IN 47978.
------------------------------------------------------------------------
           Lafayette Parish, Louisiana and Incorporated Areas
                 Docket No.: FEMA-B-1515 and FEMA-B-1724
------------------------------------------------------------------------
City of Broussard......................  City Hall, 310 East Main
                                          Street, Broussard, LA 70518.
City of Carencro.......................  City Hall, Planning Department,
                                          210 East St. Peter Street,
                                          Carencro, LA 70520.
City of Lafayette......................  Department of Planning, Zoning
                                          and Development, 220 West
                                          Willow Street, Building B,
                                          Lafayette, LA 70501.
City of Scott..........................  City Hall, 125 Lions Club Road,
                                          Scott, LA 70583.
City of Youngsville....................  City Hall, 305 Iberia Street,
                                          Youngsville, LA 70592.
Town of Duson..........................  Town Hall, 498 Toby Mouton
                                          Road, Duson, LA 70529.
Unincorporated Areas Lafayette Parish..  Department of Planning, Zoning
                                          and Development, 220 West
                                          Willow Street, Building B,
                                          Lafayette, LA 70501.
------------------------------------------------------------------------
             Carver County, Minnesota and Incorporated Areas
                         Docket No.: FEMA-B-1657
------------------------------------------------------------------------
City of Carver.........................  City Hall, 801 Jonathan Carver
                                          Parkway, Carver, MN 55315.
City of Chanhassen.....................  City Hall, Planning Department,
                                          7700 Market Boulevard,
                                          Chanhassen, MN 55317.
City of Chaska.........................  City Hall, One City Hall Plaza,
                                          Chaska, MN 55318.
City of Cologne........................  City Hall, 1211 Village
                                          Parkway, Cologne, MN 55322.
City of Mayer..........................  City Hall, 413 Blue Jay Avenue,
                                          Mayer, MN 55360.
City of New Germany....................  Carver County Courthouse,
                                          Public Health & Environment
                                          Division, 600 East 4th Street,
                                          Chaska, MN 55318.
City of Norwood Young America..........  City Hall, 310 Elm Street West,
                                          Norwood Young America, MN
                                          55368.
City of Victoria.......................  City Hall, 1670 Stieger Lake
                                          Lane, Victoria, MN 55386.
City of Waconia........................  City Hall, 201 South Vine
                                          Street, Waconia, MN 55387.
City of Watertown......................  City Hall, 309 Lewis Avenue
                                          South, Watertown, MN 55388.
Unincorporated Areas of Carver County..  Carver County Courthouse,
                                          Public Health & Environment
                                          Division, 600 East 4th Street,
                                          Chaska, MN 55318.
------------------------------------------------------------------------

[FR Doc. 2018-23383 Filed 10-25-18; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Rules and Regulations]
[Pages 21237-21239]
[FR Doc No: 2011-9141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2011-N-0118]

Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Hemorrhoid Prevention Pressure Wedge

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
hemorrhoid prevention pressure wedge into class II (special controls).
The special controls will apply to the device in order to provide a
reasonable assurance of safety and effectiveness of the device. A
hemorrhoid prevention pressure wedge provides support to the perianal
region during the labor and delivery process.

DATES: This rule is effective May 16, 2011. The classification was
applicable on January 13, 2011.

FOR FURTHER INFORMATION CONTACT: Glenn Bell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G112, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act (21 U.S.C.360c(i)), to a
predicate device that does not require premarket approval. The Agency
determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR
part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the FD&C
Act. FDA will, within 60 days of receiving this request, classify the
device by written order. This classification will be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on August 5, 2009, classifying the Hem-Avert Perianal Stabilizer
into class III, because it was not substantially equivalent to a device
that was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, or a device
which was subsequently reclassified into class I or class II. On August
17, 2009, Plexus Biomedical, Inc., submitted a petition requesting
classification of the Hem-Avert Perianal Stabilizer under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class II. (Ref. 1)
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name hemorrhoid prevention
pressure wedge, and it is identified as a hemorrhoid prevention
pressure wedge that provides mechanical support to the perianal region
during the labor and delivery process. External mechanical support of
the perianal region is intended to help prevent the occurrence of
external hemorrhoids associated with vaginal childbirth.
    FDA has identified the following risks to health associated
specifically with this type of device and the recommended measures to
mitigate these risks.

                                      Table 1--Health Risks and Mitigations
----------------------------------------------------------------------------------------------------------------
                 Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Skin/tissue trauma (e.g., rectal and/or anal      Nonclinical Analysis and Testing.
 trauma, necrosis, thinning, abrasion,            Clinical Information.
 laceration to the perineum, vulvar hematoma,     Labeling.
 sloughing).
Device failure (e.g., material failure,           Nonclinical Analysis and Testing.
 slippage).                                       Labeling.
Device failure--obstruction to the treatment      Device Description.
 area caused by inability to remove the           Labeling.
 instrument quickly.
Infection.......................................  Labeling.
Adverse tissue reaction.........................  Biocompatibility.
Pain............................................  Nonclinical Analysis and Testing.
                                                  Biocompatibility.
----------------------------------------------------------------------------------------------------------------

    FDA believes that the following special controls address the risks
to health and provide reasonable assurance of the safety and
effectiveness of the device: (1) The sale, distribution, and use of
this device are restricted to

prescription use in accordance with 21 CFR 801.109; (2) the labeling
should include specific instructions regarding the proper placement and
use of the device; (3) the device should be demonstrated to be
biocompatible; (4) mechanical bench testing of material strength should
demonstrate that the device will withstand forces encountered during
use; and (5) safety and effectiveness data should demonstrate that the
device prevents hemorrhoids in women undergoing spontaneous vaginal
delivery, in addition to general controls. Therefore, on January 13,
2011 (corrected order sent to petitioner on February 1, 2011), FDA
issued an order to the petitioner classifying the device into class II.
FDA is codifying the classification of the device by adding Sec.
884.5200.
    Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a hemorrhoid
prevention pressure wedge will need to address the issues covered in
the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the hemorrhoid prevention pressure
wedge they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the FD&C Act (21 U.S.C. 360e), and may permit small potential
competitors to enter the marketplace by lowering their costs, the
Agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. (21
U.S.C. 360k); See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008). The special controls established
by this final rule create ``requirements'' to address each identified
risk to health presented by these specific medical devices under 21
U.S.C. 360k, even though product sponsors may have flexibility in how
they meet these requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d
737, 740-42 (9th Cir. 1997).

V. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to
previously approved collections of information found in other 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. 32501-3520). The collections of information in
part 807, regarding premarket notification submissions, have been
approved under OMB control no. 0910-0120; the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control no. 0910-0485.

VI. References

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from Plexus Biomedical, Inc., August 17, 2009.

List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 884 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 884.5200 is added to subpart F to read as follows:

Sec.  884.5200  Hemorrhoid prevention pressure wedge.

    (a) Identification. A hemorrhoid prevention pressure wedge provides
mechanical support to the perianal region during the labor and delivery
process. External mechanical support of the perianal region is intended
to help prevent the occurrence of external hemorrhoids associated with
vaginal childbirth.
    (b) Classification. Class II (special controls). The special
controls for this device are:

    (1) The sale, distribution, and use of this device are restricted
to prescription use in accordance with Sec.  801.109 of this chapter.
    (2) The labeling must include specific instructions regarding the
proper placement and use of the device.
    (3) The device must be demonstrated to be biocompatible.
    (4) Mechanical bench testing of material strength must demonstrate
that the device will withstand forces encountered during use.
    (5) Safety and effectiveness data must demonstrate that the device
prevents hemorrhoids in women undergoing spontaneous vaginal delivery,
in addition to general controls.

    Dated: April 11, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-9141 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Page 66051]
[FR Doc No: 2019-25971]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87625; File No. SR-EMERALD-2019-29]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Withdrawal of Proposed Rule Change To Amend its Options Regulatory Fee

November 25, 2019.
    On August 1, 2019, MIAX Emerald, LLC (``MIAX Emerald'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change (File No. SR-EMERALD-2019-29) to amend its Options
Regulatory Fee (``ORF'').\3\ The proposed rule change was immediately
effective upon filing with the Commission pursuant to Section
19(b)(3)(A) of the Act.\4\ The proposed rule change was published for
comment in the Federal Register on August 14, 2019.\5\ The Commission
received one comment letter on the proposal.\6\ On September 30, 2019,
pursuant to Section 19(b)(3)(C) of the Act, the Commission temporarily
suspended the proposed rule change and instituted proceedings under
Section 19(b)(2)(B) of the Act to determine whether to approve or
disapprove the proposed rule change.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86606 (August 8,
2019), 84 FR 40449 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ See Notice, supra note 3.
    \6\ See Letter to Vanessa Countryman, Secretary, Commission,
from Ellen Greene, Managing Director, Securities Industry and
Financial Markets Association, dated August 27, 2019.
    \7\ See Securities Exchange Act Release No. 87168, 84 FR 53210
(October 4, 2019).
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    On November 20, 2019, the Exchange withdrew the proposed rule
change (SR-EMERALD-2019-29).
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    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-25971 Filed 11-29-19; 8:45 am]
 BILLING CODE 8011-01-P