[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26886-26889]
[FR Doc No: 2019-11938]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency?

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1935]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

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_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the 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 National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                            Chief executive officer of                                    Online location of letter of map                            Community
         State and county          Location and case No.             community               Community map repository                 revision                Date of modification       No.
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Alabama:
    Lee..........................  City of Opelika (18-   The Honorable Gary Fuller,      Engineering Department, 700    https://msc.fema.gov/portal/        Aug. 7, 2019..........       010145
                                    04-5478P).             Mayor, City of Opelika, 204     Fox Trail, Opelika, AL         advanceSearch.
                                                           South 7th Street, Opelika, AL   36803.
                                                           36803.
    Lee..........................  Unincorporated areas   The Honorable Bill English,     Lee County Building            https://msc.fema.gov/portal/        Aug. 7, 2019..........       010250
                                    of Lee County (18-04-  Chairman, Lee County Board of   Department, 100 Orr Avenue,    advanceSearch.
                                    5478P).                Commissioners, P.O. Box 666,    Opelika, AL 36801.
                                                           Opelika, AL 36803.
California: Santa Barbara........  Unincorporated areas   The Honorable Steve Lavagnino,  Santa Barbara County Public    https://msc.fema.gov/portal/        Sep. 5, 2019..........       060331
                                    of Santa Barbara       Chairman, Santa Barbara         Works Department, 130 East     advanceSearch.
                                    County (18-09-         County Board of Supervisors,    Victoria Street, Suite 200,
                                    1861P).                511 East Lakeside Parkway,      Santa Barbara, CA 93101.
                                                           Santa Barbara, CA 93454.

Colorado:
    Arapahoe.....................  City of Cherry Hills   The Honorable Russell Stewart,  Community Development          https://msc.fema.gov/portal/        Aug. 16, 2019.........       080013
                                    Village (19-08-        Mayor, City of Cherry Hills     Department, 2450 East Quincy   advanceSearch.
                                    0093P).                Village, 2450 East Quincy       Avenue, Cherry Hills
                                                           Avenue, Cherry Hills Village,   Village, CO 80113.
                                                           CO 80113.
    Douglas......................  Town of Parker (19-08- The Honorable Mike Waid,        Public Works Department,       https://msc.fema.gov/portal/        Sep. 6, 2019..........       080310
                                    0222P).                Mayor, Town of Parker, 20120    20120 East Main Street,        advanceSearch.
                                                           East Main Street, Parker, CO    Parker, CO 80138.
                                                           80138.
    Routt........................  City of Steamboat      Mr. Gary Suiter, Manager, City  Planning and Community         https://msc.fema.gov/portal/        Jul. 29, 2019.........       080159
                                    Springs (18-08-        of Steamboat Springs, P.O.      Development Department, 124    advanceSearch.
                                    0922P).                Box 775088, Steamboat           10th Street, Steamboat
                                                           Springs, CO 80477.              Springs, CO 80477.
Connecticut: New Haven...........  Town of Guilford (18-  The Honorable Matthew T. Hoey,  Building and Engineering       https://msc.fema.gov/portal/        Aug. 2, 2019..........       090077
                                    01-1576P).             III, First Selectman, Town of   Department, 50 Boston          advanceSearch.
                                                           Guilford Board of Selectmen,    Street, Guilford, CT 06437.
                                                           31 Park Street, Guilford, CT
                                                           06437.
Florida:
    Monroe.......................  City of Marathon (19-  The Honorable John Bartus,      Planning Department, 9805      https://msc.fema.gov/portal/        Aug. 22, 2019.........       120681
                                    04-2110P).             Mayor, City of Marathon, 9805   Overseas Highway, Marathon,    advanceSearch.
                                                           Overseas Highway, Marathon,     FL 33050.
                                                           FL 33050.
    Monroe.......................  Unincorporated areas   The Honorable Sylvia Murphy,    Monroe County Building         https://msc.fema.gov/portal/        Sep. 3, 2019..........       125129
                                    of Monroe County (19-  Mayor, Monroe County Board of   Department, 2798 Overseas      advanceSearch.
                                    04-2123P).             Commissioners, 102050           Highway, Suite 300,
                                                           Overseas Highway, Suite 234,    Marathon, FL 33050.
                                                           Key Largo, FL 33037.
    Monroe.......................  Unincorporated areas   The Honorable Sylvia Murphy,    Monroe County Building         https://msc.fema.gov/portal/        Aug. 26, 2019.........       125129
                                    of Monroe County (19-  Mayor, Monroe County Board of   Department, 2798 Overseas      advanceSearch.
                                    04-2180P).             Commissioners, 102050           Highway, Suite 300,
                                                           Overseas Highway, Suite 234,    Marathon, FL 33050.
                                                           Key Largo, FL 33037.
    Orange.......................  City of Orlando (18-   The Honorable Buddy W. Dyer,    Public Works Department,       https://msc.fema.gov/portal/        Aug. 27, 2019.........       120186
                                    04-5643P).             Mayor, City of Orlando, P.O.    Engineering Division, 400      advanceSearch.
                                                           Box 4990, Orlando, FL 32802.    South Orange Avenue, 8th
                                                                                Floor, Orlando, FL 32801.
    Osceola......................  Unincorporated areas   The Honorable Cheryl Grieb,     Osceola County Stormwater      https://msc.fema.gov/portal/        Aug. 30, 2019.........       120189
                                    of Osceola County      Chair, Osceola County Board     Department, 1 Courthouse       advanceSearch.
                                    (18-04-7431P).         of Commissioners, 1             Square, Suite 3100,
                                                           Courthouse Square, Suite        Kissimmee, FL 34741.
                                                           4700, Kissimmee, FL 34741.
    Palm Beach...................  Unincorporated areas   The Honorable Mack Bernard,     Palm Beach County Planning,    https://msc.fema.gov/portal/        Sep. 10, 2019.........       120192
                                    of Palm Beach County   Mayor, Palm Beach County, 360   Zoning and Building            advanceSearch.
                                    (19-04-2277P).         South County Road, Palm         Department, 2300 North Jog
                                                           Beach, FL 33480.                Road, West Palm Beach, FL
                                                                                33411.
    Pasco........................  Unincorporated areas   The Honorable Ron Oakley,       Pasco County Central           https://msc.fema.gov/portal/        Sep. 3, 2019..........       120230
                                    of Pasco County (19-   Chairman, Pasco County Board    Permitting Department, 8731    advanceSearch.
                                    04-0817P).             of Commissioners, 8731          Citizens Drive, New Port
                                                           Citizens Drive, New Port        Richey, FL 34654.
                                                           Richey, FL 34654.
    Polk.........................  Unincorporated areas   The Honorable George Lindsey    Polk County Land Development   https://msc.fema.gov/portal/        Sep. 5, 2019..........       120261
                                    of Polk County (18-    III, Chairman, Polk County      Division, 330 West Church      advanceSearch.
                                    04-1711P).             Board of Commissioners, P.O.    Street, Bartow, FL 33830.
                                                           Box 9005, Drawer BC01,
                                                           Bartow, FL 33831.
Georgia:
    Liberty......................  City of Flemington     The Honorable Paul Hawkins,     Liberty Consolidated Planning  https://msc.fema.gov/portal/        Jul. 18, 2019.........       130124
                                    (19-04-0357P).         Mayor, City of Flemington,      Commission, 100 Main Street,   advanceSearch.
                                                           156 Old Sunbury Road,           Suite 7520, Hinesville, GA
                                                           Flemington, GA 31313.           31313.

    Liberty......................  Unincorporated areas   The Honorable Donald Lovette,   Liberty County Building and    https://msc.fema.gov/portal/        Jul. 18, 2019.........       130123
                                    of Liberty County      Chairman, Liberty County        Licensing Department, 112      advanceSearch.
                                    (19-04-0357P).         Board of Commissioners, 112     North Main Street,
                                                           North Main Street,              Hinesville, GA 31313.
                                                           Hinesville, GA 31313.
Montana:
    Fergus.......................  City of Lewistown (18- Ms. Holly Phelps, Manager,      Planning/Community             https://msc.fema.gov/portal/        Aug. 26, 2019.........       300022
                                    08-1160P).             City of Lewistown, 305 West     Development Department, 305    advanceSearch.
                                                           Watson Street, Suite 3,         West Watson Street, Suite 3,
                                                           Lewistown, MT 59457.            Lewistown, MT 59457.
    Fergus.......................  Unincorporated areas   The Honorable Ross Butcher,     Fergus County Planning         https://msc.fema.gov/portal/        Aug. 26, 2019.........       300019
                                    of Fergus County (18-  Presiding Officer/              Department, 712 West Main      advanceSearch.
                                    08-1160P).             Commissioner, Fergus County     Street, Suite 101,
                                                           Board of Commissioners, 712     Lewistown, MT 59457.
                                                           West Main Street, Suite 210,
                                                           Lewistown, MT 59457.
North Carolina:
    Edgecombe....................  Town of Tarboro (18-   The Honorable Joe W. Pitt,      Planning Department, 500 Main  https://msc.fema.gov/portal/        Sep. 5, 2019..........       370094
                                    04-0633P).             Mayor, Town of Tarboro, 500     Street, Tarboro, NC 27886.     advanceSearch.
                                                           Main Street, Tarboro, NC
                                                           27886.
    Edgecombe....................  Unincorporated areas   The Honorable Leonard Wiggins,  Edgecombe County Planning      https://msc.fema.gov/portal/        Sep. 5, 2019..........       370087
                                    of Edgecombe County    Chairman, Edgecombe County      Department, 201 Saint Andrew   advanceSearch.
                                    (18-04-0633P).         Board of Commissioners, 201     Street, Tarboro, NC 27886.
                                                           Saint Andrew Street, Tarboro,
                                                           NC 27886.
North Dakota:
    McHenry......................  City of Velva (18-08-  The Honorable Jennifer Soli,    City Hall, 101 1st Street      https://msc.fema.gov/portal/        Aug. 16, 2019.........       380051
                                    0850P).                Mayor, City of Velva, P.O.      West, Velva, ND 58790.         advanceSearch.
                                                           Box 219, Velva, ND 58790.
    McHenry......................  Township of Velva (18- The Honorable James Hystad,     Township Hall, 4725 19th       https://msc.fema.gov/portal/        Aug. 16, 2019.........       380310
                                    08-0850P).             Chairman, Township of Velva,    Avenue North, Velva, ND        advanceSearch.
                                                           1920 47th Street North,         58790.
                                                           Velva, ND 58790.
Pennsylvania: Chester............  Township of West       Ms. Mimi Gleason, Manager,      Township Hall, 101 Commerce    https://msc.fema.gov/portal/        Sep. 5, 2019..........       420295
                                    Whiteland (18-03-      Township of West Whiteland,     Drive, Exton, PA 19341.        advanceSearch.
                                    2192P).                101 Commerce Drive, Exton, PA
                                                           19341.
South Carolina:
    Charleston...................  Town of Sullivan's     The Honorable Patrick M.        Building Department, 2056      https://msc.fema.gov/portal/        Aug. 28, 2019.........       455418
                                    Island (19-04-         O'Neil, Mayor, Town of          Middle Street, Sullivan's      advanceSearch.
                                    1973P).                Sullivan's Island, P.O. Box     Island, SC 29482.
                                                           427, Sullivan's Island, SC
                                                           29482.
    Lexington....................  Unincorporated areas   The Honorable Scott Whetstone,  Lexington County               https://msc.fema.gov/portal/        Aug. 30, 2019.........       450129
                                    of Lexington County    Chairman, Lexington County      Administration Building, 212   advanceSearch.
                                    (18-04-3635P).         Council, 212 South Lake         South Lake Drive, Suite 401,
                                                           Drive, Suite 601, Lexington,    Lexington, SC 29072.
                                                           SC 29072.
Texas:
    Atascosa.....................  City of Pleasanton     The Honorable Travis Hall,      Public Works Department, 740   https://msc.fema.gov/portal/        Aug. 8, 2019..........       480015
                                    (19-06-0007P).         Jr., Mayor, City of             East Hunt Street,              advanceSearch.
                                                           Pleasanton, P.O. Box 209,       Pleasanton, TX 78064.
                                                           Pleasanton, TX 78064.
    Bexar........................  City of San Antonio    The Honorable Ron Nirenberg,    Transportation and Capitol     https://msc.fema.gov/portal/        Jul. 29, 2019.........       480045
                                    (18-06-0785P).         Mayor, City of San Antonio,     Improvements Department,       advanceSearch.
                                                           P.O. Box 839966, San Antonio,   Storm Water Division, 1901
                                                           TX 78283.                       South Alamo Street, 2nd
                                                                                Floor, San Antonio, TX
                                                                                78204.
     Bexar.......................  City of San Antonio    The Honorable Ron Nirenberg,    Transportation and Capitol     https://msc.fema.gov/portal/        Jul. 22, 2019.........       480045
                                    (18-06-3896P).         Mayor, City of San Antonio,     Improvements Department,       advanceSearch.
                                                           P.O. Box 839966, San Antonio,   Storm Water Division, 1901
                                                           TX 78283.                       South Alamo Street, 2nd
                                                                                Floor, San Antonio, TX
                                                                                78204.

     Bexar.......................  Unincorporated areas   The Honorable Nelson W. Wolff,  Bexar County Public Works      https://msc.fema.gov/portal/        Jul. 22, 2019.........       480035
                                    of Bexar County (18-   Bexar County Judge, 101 West    Department, 233 North Pecos-   advanceSearch.
                                    06-2879P).             Nueva Street, 10th Floor, San   La Trinidad Street, Suite
                                                           Antonio, TX 78205.              420, San Antonio, TX 78207.
     Bexar.......................  Unincorporated areas   The Honorable Nelson W. Wolff,  Bexar County Public Works      https://msc.fema.gov/portal/        Jul. 22, 2019.........       480035
                                    of Bexar County (18-   Bexar County Judge, 101 West    Department, 233 North Pecos-   advanceSearch.
                                    06-3896P).             Nueva Street, 10th Floor, San   La Trinidad Street, Suite
                                                           Antonio, TX 78205.              420, San Antonio, TX 78207.
    Collin.......................  City of Plano (18-06-  The Honorable Harry             Engineering Department, 1520   https://msc.fema.gov/portal/        Aug. 23, 2019.........       480140
                                    3629P).                LaRosiliere, Mayor, City of     K Avenue, Suite 250, Plano,    advanceSearch.
                                                           Plano, 1520 K Avenue, Suite     TX 75074.
                                                           300, Plano, TX 75074.
    Collin.......................  City of Plano (18-06-  The Honorable Harry             Engineering Department, 1520   https://msc.fema.gov/portal/        Aug. 30, 2019.........       480140
                                    3759P).                LaRosiliere, Mayor, City of     K Avenue, Suite 250, Plano,    advanceSearch.
                                                           Plano, 1520 K Avenue, Suite     TX 75074.
                                                           300, Plano, TX 75074.
    Comal........................  City of New Braunfels  The Honorable Barron Casteel,   City Hall, 550 Landa Street,   https://msc.fema.gov/portal/        Aug. 5, 2019..........       485493
                                    (18-06-1899P).         Mayor, City of New Braunfels,   New Braunfels, TX 78130.       advanceSearch.
                                                           550 Landa Street, New
                                                           Braunfels, TX 78130.
    Hays.........................  City of Kyle (18-06-   Mr. Scott Sellers, Manager,     City Hall, 100 West Center     https://msc.fema.gov/portal/        Jul. 25, 2019.........       481108
                                    3039P).                City of Kyle, 100 West Center   Street, Kyle, TX 78640.        advanceSearch.
                                                           Street, Kyle, TX 78640.
    Kaufman......................  City of Forney (18-06- Mr. Tony Carson, Manager, City  Engineering Department, 101    https://msc.fema.gov/portal/        Aug. 30, 2019.........       480410
                                    3890P).                of Forney, 101 East Main        East Main Street, Forney, TX   advanceSearch.
                                                           Street, Forney, TX 75126.       75126.
    Smith........................  City of Tyler (18-06-  The Honorable Martin Heines,    Development Center, 423 West   https://msc.fema.gov/portal/        Sep. 3, 2019..........       480571
                                    3790P).                Mayor, City of Tyler, P.O.      Ferguson Street, Tyler, TX     advanceSearch.
                                                           Box 2039, Tyler, TX 75710.      75710.
    Smith........................  City of Tyler (19-06-  The Honorable Martin Heines,    Development Center, 423 West   https://msc.fema.gov/portal/        Sep. 3, 2019..........       480571
                                    0647P).                Mayor, City of Tyler, P.O.      Ferguson Street, Tyler, TX     advanceSearch.
                                                           Box 2039, Tyler, TX 75710.      75710.
    Smith........................  Unincorporated areas   The Honorable Nathaniel Moran,  Smith County Road and Bridge   https://msc.fema.gov/portal/        Sep. 3, 2019..........       481185
                                    of Smith County (18-   Smith County Judge, 200 East    Department, 1700 West Claude   advanceSearch.
                                    06-3790P).             Ferguson Street, Suite 100,     Street, Tyler, TX 75702.
                                                           Tyler, TX 75702.
    Tarrant......................  City of Fort Worth     The Honorable Betsy Price,      City Hall, 200 Texas Street,   https://msc.fema.gov/portal/        Jul. 5, 2019..........       480596
                                    (18-06-2091P).         Mayor, City of Fort Worth,      Fort Worth, TX 76102.          advanceSearch.
                                                           200 Texas Street, Fort Worth,
                                                           TX 76102.
    Tarrant......................  City of Grand Prairie  The Honorable Ron Jensen,       Development Center, 206 West   https://msc.fema.gov/portal/        Sep. 3, 2019..........       485472
                                    (19-06-0321P).         Mayor, City of Grand Prairie,   Church Street, Grand           advanceSearch.
                                                           P.O. Box 534045, Grand          Prairie, TX 75050.
                                                           Prairie, TX 75053.
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[FR Doc. 2019-11938 Filed 6-7-19; 8:45 am]
 BILLING CODE 9110-12-P


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Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........        2019           7          10  ................................
     year.                                      ..........  ..........  ..........        2019           3          10
                                               ---------------------------------------------------------------------------------------------------------
                                                From:
                                                To:                                 ..........
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year.  ..........  ..........  ..........        2019           7          10  ................................
                                                ..........  ..........  ..........        2019           3          10
                                               ---------------------------------------------------------------------------------------------------------
                                                From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.
    Small Business: A small one-time administrative burden of up to $300 per year on each affected small entity.
    Wages: None.
    Growth: None.
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    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 20) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) and (f) 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.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Medical Device De Novo Classification Process (OMB Control
Number 0910-0844)--Revision.
    Description: This final rule implements the medical device De Novo
classification process under section 513(f)(2) of the FD&C Act, which
provides a pathway for certain new types of devices to obtain marketing
authorization as class I or class II devices, rather than remaining
automatically designated as a class III device, which would require
premarket approval under the postamendments device classification
section of the FD&C Act (section 513(f)(1)).
    On October 30, 2017, FDA issued a final guidance (De Novo Program
guidance) (Ref. 5) to provide recommendations on the process for the
submission and review of a De Novo request. The information collections
associated with the guidance are approved under OMB control number
0910-0844. We provide below a revised burden estimate for the De Novo
classification process as described in this final rule.
    Section 860.200 (this final rule renumbers proposed Sec.  860.201
as Sec.  860.200) explains the purpose of the De Novo Classification
regulations and provides the applicability of a De Novo request
submission. Sections 860.210 and 860.220 (this final rule renumbers
proposed Sec.  860.223 and Sec.  860.234 as Sec.  860.210 and Sec.
860.220) describe the format and content, respectively, of a De Novo
request. Section 860.230 (this final rule renumbers proposed Sec.
860.245 as Sec.  860.230) describes the conditions under which FDA may
refuse to accept a De Novo request. Section 860.240(b) (this final rule
renumbers proposed Sec.  860.256(b) as Sec.  860.240(b)) provides for
supplemental, amendatory, or additional information for a pending De
Novo request. Section 860.250(a)(4) (this final rule renumbers proposed
Sec.  860.267(a)(4) as Sec.  860.250(a)(4)) provides that a requester
may submit a written notice to FDA that the De Novo request has been
withdrawn.
    Description of Respondents: Respondents to the information
collection are medical device manufacturers seeking to market medical
device products that have been automatically designated as class III
under section 513(f)(1) of the FD&C Act.

                                                     Table 3--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                         Number of       Number of     Total annual                                                       operating  and
      Activity; 21 CFR section          respondents   responses  per     responses       Average burden  per response       Total hours     maintenance
                                                         respondent                                                                            costs
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De Novo request--860.200, 860.210,                68               1              68  182...............................          12,376             $88
 860.220, 860.230, 860.240(b).
Written notice of withdrawal--                     5               1               5  0.17 (10 minutes).................               1               7
 860.250(a)(4).
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ..............  ..............  ..............  ..................................          12,377              95
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers have been rounded.

    The information collection request (ICR) previously approved for
the De Novo classification process (OMB control number 0910-0844),
includes separate information collections (ICs) for De Novo requests
submitted under section 513(f)(2)(i) of the FD&C Act (estimated 100-
hour burden per response) and those submitted under section
513(f)(2)(ii) (estimated 180-hour burden per response), with burden
estimates further separated by those sent to CDRH and those sent to the
Center for Biologics Evaluation and Research.
    For administrative efficiency, in this ICR revision, we are
consolidating the separate ICs for requests submitted under section
513(f)(2)(i) or (ii) of the FD&C Act into a single IC for all De Novo
requests submitted to FDA. Therefore, this final rule simply provides a
burden estimate for all De Novo requests without distinguishing between
those submitted under 513(f)(2)(i) or (ii) of the FD&C Act. This
estimate includes estimated burdens associated with the initial request
(purpose and applicability in Sec.  860.200), format and content (Sec.
860.210 and Sec.  860.220), supplements and amendments (Sec.
860.240(b)), and time to ensure that all the format and content
requirements are met before submission (Sec.  860.230). Based on our
recent experience with the De Novo Program, FDA estimates that the
average burden per response for a De Novo request is 182 hours.
Additionally, we adjusted the estimated number of respondents based on
updated data.
    The estimated burden for Sec.  860.230 includes 2 hours per
response for manufacturers to review their De Novo request for
compliance with the acceptance criteria listed in Sec.  860.230 to
determine if it is complete and to complete the checklists recommended
in the guidance ``Acceptance Review for De Novo Classification
Requests'' (Ref.16). The information collections contained in the
guidance, including 2 hours for review of the De Novo request for
completeness and the checklists, were approved by OMB since publication
of the proposed rule.
    We estimate that the average burden per response for written notice
of withdrawal of a De Novo request, as described in Sec.
860.250(a)(4), is 10 minutes (0.17 hours). The burden table in the
proposed rule erroneously listed 10 hours, rather than 10 minutes, for
the average burden per response. We have corrected the error. The
average burden per response is based on estimates by FDA administrative
and technical staff who are familiar with the requirements for
submission of a De Novo request (and related materials), have consulted
and advised manufacturers on submissions, and have reviewed the
documentation submitted. We expect that we will receive approximately
five notices of withdrawal per year. There is no change to the
currently approved burden estimate for withdrawal of a De Novo request.
    These adjustments resulted in a 1,647-hour increase to the
previously approved total burden estimate.
    We received several comments related to the proposed rule.
Descriptions of the comments on the proposed rule and FDA's responses
are provided in section V of this final rule. Comments and responses
related to the provisions that underlie the information collection are
described in the following sections: section V.B, regarding general
comments; section V.D, De Novo request information disclosure; section
V.F, regarding definitions; section V.G, regarding De Novo request
format; section V.H, regarding De Novo request content; section V.I,
regarding criteria for accepting a De Novo request; section V.J,
regarding criteria for granting or declining a De Novo request; and
section V.K, regarding availability of the De Novo classification
process for combination products. We have not made changes to the
estimated burden as a result of the comments.
    The estimate of the annual reporting burden provided in the
proposed rule included printing and shipping for the complete paper
submission and eCopy. Under Sec.  860.210 of the final rule, each De
Novo request must be provided as a single version in electronic format.
Therefore, we have adjusted the operating and maintenance cost in the
final rule to include the cost of the eCopy and shipping of the eCopy.
    The cost per eCopy (CDs, DVDs, and flash drives) ranges from $0.25
to $2.50 per eCopy. All forms of eCopy media cost roughly $0.22 to
ship. We estimate the average cost per eCopy, plus shipping, for a De
Novo request or a request for withdrawal to be $1.30 per submission.
    The annual cost estimate for De Novo requests is $88 (68
submissions x $1.30) (rounded). The annual cost estimate for requests
for withdrawal is $7 (5 requests x $1.30) (rounded). Therefore, we
estimate the total annual operating and maintenance costs of this
information collection to be $95. This is a decrease of $7,188 to the
currently approved total annual operating and maintenance cost
estimate.
    This final rule also refers to previously approved collections of
information. These collections of information are subject to review by
OMB under the PRA. The collections of information in the guidance
entitled ``De Novo Classification Process (Evaluation of Automatic
Class III Designation)'' (Ref. 5) have been approved under OMB control
number 0910-0844; the collections of information in the guidance
entitled ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program--Guidance for Industry and Food
and Drug Administration Staff'' (Ref. 13) have been approved under OMB
control number 0910-0756; the collections of information in the
guidances entitled ``Guidance for Industry and Food and Drug
Administration Staff--User Fees

for 513(g) Requests for Information'' (Ref. 17) and ``FDA and Industry
Procedures for Section 513(g) Requests for Information under the
Federal Food, Drug, and Cosmetic Act--Guidance for Industry and Food
and Drug Administration Staff'' (Ref. 18) have been approved under OMB
control number 0910-0705; and the collections of information in the
guidance entitled ``Emergency Use Authorization of Medical Products and
Related Authorities'' (Ref. 19) have been approved under OMB control
number 0910-0595. The collections of information in Title 21 of the
Code of Federal Regulations (CFR) are approved under the following OMB
control numbers: part 3 under 0910-0523; parts 50 and 56 under 0910-
0130; part 54 under 0910-0396; part 58 under 0910-0119; parts 801 and
809 under 0910-0485; part 807, subpart E, under 0910-0120; part 812
under 0910-0078; part 814, subparts A through E under 0910-0231; part
814, subpart H under 0910-0332; part 820 under 0910-0073; part 860,
subpart C under 0910-0138.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.

XII. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA, ``Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices.
2. FDA, ``Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices.
3. FDA, ``Factors to Consider When Making Benefit-Risk
Determinations in Medical Device Premarket Approval and De Novo
Classifications,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-making-benefit-risk-determinations-medical-device-premarket-approval-and-de.
4. FDA, ``Patient Preference Information--Voluntary Submission,
Review in Premarket Approval Applications, Humanitarian Device
Exemption Applications, and De Novo Requests, and Inclusion in
Decision Summaries and Device Labeling,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-preference-information-voluntary-submission-review-premarket-approval-applications.
5. FDA, ``De Novo Classification Process (Evaluation of Automatic
Class III Designation),'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation.
6. FDA, CDRH Patient Engagement web page, available at https://www.fda.gov/about-fda/about-center-devices-and-radiological-health/cdrh-patient-engagement.
7. FDA, ``Procedures for Meetings of the Medical Devices Advisory
Committee,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-meetings-medical-devices-advisory-committee.
8. FDA, ``eCopy Program for Medical Device Submissions,'' available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
9. FDA, ``Consideration of Uncertainty in Making Benefit-Risk
Determinations in Medical Device Premarket Approvals, De Novo
Classifications, and Humanitarian Device Exemptions,'' available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consideration-uncertainty-making-benefit-risk-determinations-medical-device-premarket-approvals-de.
10. FDA, ``The 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)],'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.
11. FDA, ``Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
12. FDA, ``The Least Burdensome Provisions: Concept and
Principles,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
13. FDA, ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.
14. FDA, ``Use of Electronic Health Record Data in Clinical
Investigations,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry.
15. FDA, ``Recommended Content and Format of Non-Clinical Bench
Performance Testing Information in Premarket Submissions,''
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket.
16. FDA, ``Acceptance Review for De Novo Classification Requests,''
available at https://www.fda.gov/regulatory-information/search-fda-
guidance-

documents/acceptance-review-de-novo-classification-requests.
17. FDA's guidance ``Guidance for Industry and Food and Drug
Administration Staff--User Fees for 513(g) Requests for
Information,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-information.
18. FDA's guidance ``FDA and Industry Procedures for Section 513(g)
Requests for Information under the Federal Food, Drug, and Cosmetic
Act,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
19. ``Emergency Use Authorization of Medical Products and Related
Authorities,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities.
20. FDA's full analysis of economic impacts is available in the
Docket No. FDA-2018-N-0236 for this rule and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, 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 860 is amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for part 860 is revised to read as follows:

    Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i,
360j, 371, 374.

0
2. In part 860, remove all references to ``the act'' and add in their
place ``the Federal Food, Drug, and Cosmetic Act''.

0
3. Amend Sec.  860.1 by revising paragraph (b) to read as follows:

Sec.  860.1  Scope.

* * * * *
    (b) This part prescribes the criteria and procedures to be used by
advisory committees, including classification panels, where applicable,
in making their recommendations, and by the Commissioner in making the
Commissioner's determinations regarding the class of regulatory control
(class I, class II, or class III) appropriate for particular devices.
Supplementing the general Food and Drug Administration procedures
governing advisory committees (part 14 of this chapter), this part also
provides procedures for manufacturers, importers, and other interested
persons to participate in proceedings to classify and reclassify
devices. This part also describes the type of data required for
determination of the safety and effectiveness of a device, and the
circumstances under which information submitted to advisory committees,
including classification panels, or to the Commissioner in connection
with classification and reclassification proceedings, will be available
to the public.

0
4. Revise Sec.  860.3 to read as follows:

Sec.  860.3  Definitions.

    For the purposes of this part:
    Class means one of the three categories of regulatory control for
medical devices, defined as follows:
    Class I means the class of devices that are subject only to the
general controls authorized by or under sections 501 (adulteration),
502 (misbranding), 510 (registration), 516 (banned devices), 518
(notification and other remedies), 519 (records and reports), and 520
(general provisions) of the Federal Food, Drug, and Cosmetic Act. A
device is in class I if:
    (1) General controls are sufficient to provide reasonable assurance
of the safety and effectiveness of the device, or
    (2) There is insufficient information from which to determine that
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device or to establish special controls
to provide such assurance, but the device is not life-supporting or
life-sustaining, or for a use which is of substantial importance in
preventing impairment of human health, and which does not present a
potential unreasonable risk of illness or injury.
    Class II means the class of devices that is or eventually will be
subject to special controls. A device is in class II if general
controls alone are insufficient to provide reasonable assurance of its
safety and effectiveness and there is sufficient information to
establish special controls, including the promulgation of performance
standards, postmarket surveillance, patient registries, development and
dissemination of guidelines (including guidelines for the submission of
clinical data in premarket notification submissions in accordance with
section 510(k) of the Federal Food, Drug, and Cosmetic Act),
recommendations, and other appropriate actions as the Commissioner
deems necessary to provide such assurance. For a device that is
purported or represented to be for use in supporting or sustaining
human life, the Commissioner shall examine and identify the special
controls, if any, which are necessary to provide adequate assurance of
safety and effectiveness, and describe how such controls provide such
assurance.
    Class III means the class of devices for which premarket approval
is or will be required in accordance with section 515 of the Federal
Food, Drug, and Cosmetic Act. A device is in class III if insufficient
information exists to determine that general controls are sufficient to
provide reasonable assurance of its safety and effectiveness, or that
application of special controls described in the definition of ``Class
II'' in this section in addition to general controls, would provide
such assurance, and if, in addition, the device is life-supporting or
life-sustaining, or for a use which is of substantial importance in
preventing impairment of human health, or if the device presents a
potential unreasonable risk of illness or injury.
    Classification panel means one of the several advisory committees
established by the Commissioner under section 513 of the Federal Food,
Drug, and Cosmetic Act and part 14 of this chapter for the purpose of
making recommendations to the Commissioner on the classification and
reclassification of devices and for other purposes prescribed by the
Federal Food, Drug, and Cosmetic Act or by the Commissioner.
    Classification regulation means a section under parts 862 through
892 of this chapter that contains the identification (general
description and intended use) and classification (class I, II or III)
of a single device type or more than one related device type(s).
    Commissioner means the Commissioner of Food and Drugs, Food and
Drug Administration, United States Department of Health and Human
Services, or the Commissioner's designee.
    De Novo request means any submission under section 513(f)(2) of the
Federal Food, Drug, and Cosmetic Act for a medical device, requesting
classification into class I or class II, including all information
submitted with or incorporated by reference therein.
    FDA means the Food and Drug Administration.
    General controls mean the controls authorized by or under sections
501 (adulteration), 502 (misbranding), 510 (registration, listing, and
premarket notification), 516 (banned devices), 518 (notification and
other remedies), 519 (records, reports, and unique device
identification), and 520 (general provisions) of the Federal Food,
Drug, and Cosmetic Act.

    Generic type of device means a grouping of devices that do not
differ significantly in purpose, design, materials, energy source,
function, or any other feature related to safety and effectiveness, and
for which similar regulatory controls are sufficient to provide
reasonable assurance of safety and effectiveness.
    Implant means a device that is placed into a surgically or
naturally formed cavity of the human body. A device is regarded as an
implant for the purpose of this part only if it is intended to remain
implanted continuously for a period of 30 days or more, unless the
Commissioner determines otherwise to protect human health.
    Life-supporting or life-sustaining device means a device that is
essential to, or that yields information that is essential to, the
restoration or continuation of a bodily function important to the
continuation of human life.
    Petition means a submission seeking reclassification of a device in
accordance with Sec.  860.123.
    Special controls mean the controls necessary to provide reasonable
assurance of safety and effectiveness for a generic type of device that
is class II. Special controls include performance standards,
performance testing, postmarket surveillance, patient registries,
development and dissemination of guidelines (including guidelines for
the submission of clinical data in premarket notification submissions
in accordance with section 510(k) of the Federal Food, Drug, and
Cosmetic Act), recommendations, and other appropriate actions, as the
Commissioner deems necessary to provide such assurance.

0
5. Amend Sec.  860.5 by adding paragraph (g) to read as follows:

Sec.  860.5   Confidentiality and use of data and information submitted
in connection with classification and reclassification.

* * * * *
    (g) Confidentiality of data and information in a De Novo file is as
follows:
    (1) A ``De Novo file'' includes all data and information from the
requester submitted with or incorporated by reference in the De Novo
request, any De Novo supplement, or any other related submission
relevant to the administrative file, as defined in Sec.  10.3(a) of
this chapter. Any record in the De Novo file will be available for
public disclosure in accordance with the provisions of this section and
part 20 of this chapter.
    (2) The existence of a De Novo file may not be disclosed by FDA
before an order granting the De Novo request is issued unless it
previously has been publicly disclosed or acknowledged by the De Novo
requester.
    (3) Before an order granting the De Novo request is issued, data or
information contained in the De Novo file is not available for public
disclosure, except to the extent the existence of the De Novo file is
disclosable under paragraph (g)(2) of this section and such data or
information has been publicly disclosed or acknowledged by the De Novo
requester.
    (4) After FDA issues an order granting a De Novo request, the data
and information in the De Novo file that are not exempt from release
under the Freedom of Information Act, 5 U.S.C. 552, are immediately
available for public disclosure.

0
6. Add subpart D, consisting of Sec. Sec.  860.200 through 860.260, to
read as follows:
Subpart D--De Novo Classification
Sec.
860.200 Purpose and applicability.
860.210 De Novo request format.
860.220 De Novo request content.
860.230 Accepting a De Novo request.
860.240 Procedures for review of a De Novo request.
860.250 Withdrawal of a De Novo request.
860.260 Granting or declining a De Novo request.

Subpart D--De Novo Classification

Sec.  860.200  Purpose and applicability.

    (a) The purpose of this part is to establish an efficient,
transparent, and thorough process to facilitate De Novo classification
into class I or class II for devices for which there is no legally
marketed device on which to base a review of substantial equivalence
and which meet the definition of class I or class II as described in
section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and Sec.
860.3.
    (b) De Novo requests can be submitted for a single device type:
    (1) After receiving a not substantially equivalent determination in
response to a premarket notification (510(k)), or
    (2) If a person determines there is no legally marketed device upon
which to base a determination of substantial equivalence.

Sec.  860.210  De Novo request format.

    (a) Each De Novo request or information related to a De Novo
request pursuant to this part must be formatted in accordance with this
section. Each De Novo request must be provided as a single version in
electronic format. These materials must:
    (1)(i) For devices regulated by the Center for Devices and
Radiological Health, be sent to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (ii) For devices regulated by the Center for Biologics Evaluation
and Research, be sent to the current address displayed on the website
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.
    (2) Be signed by the requester or an authorized representative.
    (3) Be designated ``De Novo Request'' in the cover letter.
    (4) Have all content used to support the request written in, or
translated into, English.

Sec.  860.220  De Novo request content.

    (a) Unless the requester justifies an omission in accordance with
paragraph (c) of this section, a De Novo request must include:
    (1) Table of contents. A table of contents that specifies the
volume (if the De Novo request contains more than one volume) and page
number for each item.
    (2) Administrative information. The name, address, phone, and email
address of the requester and U.S. representative, if applicable. The
establishment registration number, if applicable, of the owner or
operator submitting the De Novo request.
    (3) Regulatory history. Identify any prior submissions to FDA for
the device, including, but not limited to, any premarket notifications
(510(k)s) submitted under part 807 of this chapter; applications for
premarket approval (PMAs) submitted under part 814 of this chapter;
applications for humanitarian device exemption (HDE) submitted under
part 814 of this chapter; applications for investigational device
exemption (IDEs) submitted under part 812 of this chapter; requests for
designation (RFD) under Sec.  3.7 of this chapter; requests for
information under section 513(g) of the Federal Food, Drug, and
Cosmetic Act; applications for emergency use authorization (EUA) under
section 564 of the Federal Food, Drug, and Cosmetic Act; pre-
submissions, or previously submitted De Novo requests; or state that
there have been no prior submissions.
    (4) Device name. The generic name of the device as well as any
proprietary name or trade name.
    (5) Indications for use. A general description of the disease or
condition the device is intended to diagnose, treat, prevent, cure or
mitigate, or affect the structure or function of the body, including a
description of the patient

population for which the device is intended. The indications for use
include all the labeled patient uses of the device, including if it is
prescription or over-the-counter.
    (6) Device description. A complete description of:
    (i) The device, including, where applicable, pictorial
representations, device specifications, and engineering drawings;
    (ii) Each of the functional components or ingredients of the
device, if the device consists of more than one physical component or
ingredient;
    (iii) The properties of the device relevant to the diagnosis,
treatment, prevention, cure, or mitigation of a disease or condition
and/or the effect of the device on the structure or function of the
body;
    (iv) The principles of operation of the device; and
    (v) The relevant FDA assigned reference number(s) for any medical
devices (such as accessories or components) that are intended to be
used with the device and that are already legally marketed.
    (7) Alternative practices and procedures. A description of existing
alternative practices or procedures that are used in diagnosing,
treating, preventing, curing, or mitigating the disease or condition
for which the device is intended or which similarly affect the
structure or function of the body and that are known or should
reasonably be known to the requester.
    (8) Classification summary. (i) For devices not the subject of a
previous submission under section 510(k) of the Federal Food, Drug, and
Cosmetic Act, a complete description of:
    (A) The searches used to establish that no legally marketed device
of the same type exists.
    (B) A list of classification regulations, PMAs, HDEs, premarket
notifications (510(k)s), EUAs, and/or product codes regarding devices
that are potentially similar to the subject device.
    (C) A rationale explaining how the device that is the subject of
the De Novo request is different from the devices covered by the
classification regulations, PMAs, HDEs, 510(k)s, EUAs, and/or product
codes identified in paragraph (a)(8)(i)(B) of this section.
    (ii) For devices which were the subject of a previous submission
under section 510(k) of the Federal Food, Drug, and Cosmetic Act that
were determined not substantially equivalent (NSE), the relevant 510(k)
number, along with a summary of the search performed to confirm the
device has not been classified or reclassified since the date the NSE
order was issued by FDA pursuant to Sec.  807.100(a) of this chapter.
    (9) Summary of risks and mitigations. A summary of probable risks
to health associated with use of the device that are known or should
reasonably be known to the requester and the proposed mitigations,
including general controls and, if the classification recommendation
from paragraph (a)(11) of this section is class II, special controls
for each risk. For each mitigation measure that involves specific
performance testing or labeling, the De Novo request must provide a
reference to the associated section or pages for the supporting
information in the De Novo request.
    (10) Proposed special controls. If the classification
recommendation from paragraph (a)(11) of this section is class II, then
the summary must include an initial draft proposal for applicable
special controls and a description of how those special controls
provide reasonable assurance of safety and effectiveness.
    (11) Classification recommendation. The recommended class (I or II)
must be identified and must be supported by a description of why
general controls, or general and special controls, are adequate to
provide reasonable assurance of safety and effectiveness.
    (12) Standards. Reference to any published voluntary consensus
standards that are relevant to any aspect of the safety or
effectiveness of the device and that are known or should reasonably be
known to the requester. Such standards include voluntary consensus
standards whether recognized or not yet recognized under section 514(c)
of the Federal Food, Drug, and Cosmetic Act. Provide adequate
information to demonstrate how the device meets, or justify any
deviation from, the referenced standard.
    (13) Summary of studies. An abstract of any information or report
described in the De Novo request under paragraph (a)(16)(ii) of this
section and a summary of the results of technical data submitted under
paragraph (a)(15) of this section. Each such study summary must include
a description of the objective of the study, a description of the
experimental design of the study, a brief description of how the data
were collected and analyzed, and a brief description of the results,
whether positive, negative, or inconclusive. This section must also
include the following:
    (i) A summary of each nonclinical study submitted in the De Novo
request;
    (ii) A summary of each clinical investigation involving human
subjects submitted in the De Novo request, including a discussion of
investigation design, subject selection and exclusion criteria,
investigation population, investigation period, safety and
effectiveness data, adverse reactions and complications, subject
discontinuation, subject complaints, device failures (including
unexpected software events, if applicable) and replacements, results of
statistical analyses of the clinical investigations, contraindications
and precautions for use of the device, and other information from the
clinical investigations as appropriate. Any investigation conducted
under an investigational device exemption (IDE) under part 812 of this
chapter must be identified as such.
    (14) Benefit and risk considerations. A discussion demonstrating
that:
    (i) The data and information in the De Novo request constitute
valid scientific evidence within the meaning of Sec.  860.7(c) and
    (ii) Pursuant to Sec.  860.7, when subject to general controls, or
general and special controls, the probable benefit to health from use
of the device outweighs any probable injury or illness from such use.
    (15) Technical sections. The following technical sections, which
must contain data and information in sufficient detail to permit FDA to
determine whether to grant or decline the De Novo request:
    (i) A section containing the results of the nonclinical studies of
the device, including, as appropriate, microbiological, toxicological,
immunological, biocompatibility, stress, wear, shelf life, electrical
safety, electromagnetic compatibility, and other laboratory or animal
tests. Information on nonclinical studies must include protocols and
complete test reports for each study. For those nonclinical studies
subject to part 58 of this chapter, this section must include a
statement that each such study was conducted in compliance with such
regulations, or, if the study was not conducted in compliance with part
58 of this chapter, a brief statement of the reason for the
noncompliance.
    (ii) For all devices that incorporate software, a section
containing all relevant software information and testing, including,
but not limited to, appropriate device hazard analysis, hardware, and
system information.
    (iii) A section containing results of each clinical investigation
of the device involving human subjects, including clinical protocols,
number of investigators and subjects per investigator, investigation
design, subject selection and exclusion criteria, investigation
population, investigation period, safety and effectiveness data,
adverse reactions and complications,

subject discontinuation, subject complaints, device failures (including
unexpected software events if applicable) and replacements, tabulations
of data from all individual subject report forms and copies of such
forms for each subject who died during a clinical investigation or who
did not complete the investigation, results of statistical analyses of
the results of the clinical investigations, contraindications,
warnings, precautions, and other limiting statements relevant to the
use of the device type, and any other appropriate information from the
clinical investigations. Any investigation conducted under an IDE under
part 812 of this chapter must be identified as such. Information on
clinical investigations involving human subjects must include the
following:
    (A) For clinical investigations conducted in the United States, a
statement with respect to each investigation that it either was
conducted in compliance with the institutional review board regulations
in part 56 of this chapter, or was not subject to the regulations under
Sec.  56.104 or Sec.  56.105 of this chapter, and that it was conducted
in compliance with the informed consent regulations in part 50 of this
chapter; or if the investigation was not conducted in compliance with
those regulations, a brief statement of the reason for the
noncompliance. Failure or inability to comply with these requirements
does not justify failure to provide information on a relevant clinical
investigation.
    (B) For clinical investigations conducted in the United States, a
statement that each investigation was conducted in compliance with part
812 of this chapter concerning sponsors of clinical investigations and
clinical investigators, or if the investigation was not conducted in
compliance with those regulations, a brief statement of the reason for
the noncompliance. Failure or inability to comply with these
requirements does not justify failure to provide information on a
relevant clinical investigation.
    (C) For clinical investigations conducted outside the United States
that are intended to support the De Novo request, the requirements
under Sec.  812.28 of this chapter apply. If any such investigation was
not conducted in accordance with good clinical practice (GCP) as
described in Sec.  812.28(a) of this chapter, include either a waiver
request in accordance with Sec.  812.28(c) of this chapter or a brief
statement of the reason for not conducting the investigation in
accordance with GCP and a description of steps taken to ensure that the
data and results are credible and accurate and that the rights, safety,
and well-being of subjects have been adequately protected. Failure or
inability to comply with these requirements does not justify failure to
provide information on a relevant clinical investigation.
    (D) A statement that each investigation has been completed per the
protocol or a summary of any protocol deviations.
    (E) A financial certification or disclosure statement or both as
required by part 54 of this chapter.
    (F) For a De Novo request that relies primarily on data from a
single investigator at one investigation site, a justification showing
that these data and other information are sufficient to reasonably
demonstrate the safety and effectiveness of the device when subject to
general controls or general and special controls, and to ensure that
the results from a site are applicable to the intended population.
    (G) A discussion of how the investigation data represent clinically
significant results, pursuant to Sec.  860.7(e).
    (16) Other information. (i) A bibliography of all published reports
not submitted under paragraph (a)(15) of this section, whether adverse
or supportive, known to or that should reasonably be known to the
requester and that concern the safety or effectiveness of the device.
    (ii) An identification, discussion, and analysis of any other data,
information, or report relevant to an evaluation of the safety and
effectiveness of the device known to or that should reasonably be known
to the requester from any source, foreign or domestic, including
information derived from investigations other than those in the request
and from commercial marketing experience.
    (iii) Copies of such published reports or unpublished information
in the possession of or reasonably obtainable by the requester, if
requested by FDA.
    (17) Samples. If requested by FDA, one or more samples of the
device and its components. If it is impractical to submit a requested
sample of the device, the requester must name the location at which FDA
may examine and test one or more of the devices.
    (18) Labeling and advertisements. Labels, labeling, and
advertisements sufficient to describe the device, its intended use, and
the directions for its use. Where applicable, photographs or
engineering drawings must be supplied.
    (19) Other information. Such other information as is necessary to
determine whether general controls or general and special controls
provide reasonable assurance of safety and effectiveness of the device.
    (b) Pertinent information in FDA files specifically referred to by
a requester may be incorporated into a De Novo request by reference.
Information submitted to FDA by a person other than the requester will
not be considered part of a De Novo request unless such reference is
authorized in writing by the person who submitted the information.
    (c) If the requester believes that certain information required
under paragraph (a) of this section to be in a De Novo request is not
applicable to the device that is the subject of the De Novo request,
and omits any such information from the De Novo request, the requester
must submit a statement that specifies the omitted information and
justifies the omission. The statement must be submitted as a separate
section in the De Novo request and listed in the table of contents. If
the justification for the omission is not accepted by FDA, FDA will so
notify the requester.
    (d) The requester must update the pending De Novo request with new
safety and effectiveness information learned about the device from
ongoing or completed studies and investigations that may reasonably
affect an evaluation of the safety or effectiveness of the device as
such information becomes available.

Sec.  860.230  Accepting a De Novo request.

    (a) The acceptance of a De Novo request means that FDA has made a
threshold determination that the De Novo request contains the
information necessary to permit a substantive review. Within 15 days
after a De Novo request is received by FDA, FDA will notify the
requester whether the De Novo request has been accepted.
    (b) If FDA does not find that any of the reasons in paragraph
(c)(1) of this section for refusing to accept the De Novo request apply
or FDA fails to complete the acceptance review within 15 days, FDA will
accept the De Novo request for review and will notify the requester.
The notice will include the De Novo request reference number and the
date FDA accepted the De Novo request. The date of acceptance is the
date that an accepted De Novo request was received by FDA.
    (c)(1) FDA may refuse to accept a De Novo request if any of the
following applies:
    (i) The requester has an open or pending premarket submission or
reclassification petition for the device;
    (ii) The De Novo request is incomplete because it does not on its
face contain all the information required

under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act or
does not contain each of the items required under this part, or a
justification for omission of any item;
    (iii) The De Novo request is not formatted as required under Sec.
860.210;
    (iv) The De Novo request is for multiple devices and those devices
are of more than one type; or
    (v) The requester has not responded to, or has failed to provide a
rationale for not responding to, deficiencies identified by FDA in
previous submissions for the same device, including those submissions
described in Sec.  860.220(a)(3).
    (2) If FDA refuses to accept a De Novo request, FDA will notify the
requester of the reasons for the refusal. The notice will identify the
deficiencies in the De Novo request that prevent accepting and will
include the De Novo request reference number.
    (3) If FDA refuses to accept a De Novo request, the requester may
submit the additional information necessary to comply with the
requirements of section 513(f)(2) of the Federal Food, Drug, and
Cosmetic Act and this part. The additional information must include the
De Novo request reference number of the original submission. If the De
Novo request is subsequently accepted, the date of acceptance is the
date FDA receives the additional information.

Sec.  860.240  Procedures for review of a De Novo request.

    (a) FDA will begin substantive review of a De Novo request after
the De Novo request is accepted under Sec.  860.230. Within 120 days
after receipt of a De Novo request or receipt of additional information
that results in the De Novo request being accepted under Sec.  860.230,
FDA will review the De Novo request and send the requester an order
granting the De Novo request under Sec.  860.260(a) or an order
declining the De Novo request under 860.260(b).
    (b) A requester may supplement or amend a pending De Novo request
to revise existing information or provide additional information.
    (1) FDA may require additional information regarding the device
that is necessary for FDA to complete the review of the De Novo
request.
    (2) Additional information submitted to FDA must include the
reference number assigned to the original De Novo request and, if
submitted on the requester's own initiative, the reason for submitting
the additional information.
    (c) Prior to granting or declining a De Novo request, FDA may
inspect relevant facilities to help determine:
    (1) That clinical or nonclinical data were collected in a manner
that ensures that the data accurately represents the benefits and risks
of the device; or
    (2) That implementation of Quality System Regulation (part 820 of
this chapter) requirements, in addition to other general controls and
any specified special controls, provide adequate assurance that
critical and/or novel manufacturing processes produce devices that meet
specifications necessary to ensure reasonable assurance of safety and
effectiveness.

Sec.  860.250  Withdrawal of a De Novo request.

    (a) FDA considers a De Novo request to have been withdrawn if:
    (1) The requester fails to provide a complete response to a request
for additional information pursuant to Sec.  860.240(b)(1) within 180
days after the date FDA issues such request;
    (2) The requester fails to provide a complete response to the
deficiencies identified by FDA pursuant to Sec.  860.230(c)(2) within
180 days of the date notification was issued by FDA;
    (3) The requester does not permit an authorized FDA employee an
opportunity to inspect the facilities, pursuant to Sec.  860.240(c), at
a reasonable time and in a reasonable manner, and to have access to
copy and verify all records pertinent to the De Novo request; or
    (4) The requester submits a written notice to FDA that the De Novo
request has been withdrawn.
    (b) If a De Novo request is withdrawn, the Agency will notify the
requester. The notice will include the De Novo request reference number
and the date FDA considered the De Novo request withdrawn.

Sec.  860.260  Granting or declining a De Novo request.

    (a)(1) FDA will issue to the requester an order granting a De Novo
request if none of the reasons in paragraph (c) of this section for
declining the De Novo request applies.
    (2) If FDA grants a De Novo request, within 30 days after the
issuance of an order granting the De Novo request, FDA will publish in
the Federal Register a notice of the classification order, including
any special controls.
    (b) If FDA declines a De Novo request, FDA will issue a written
order to the requester.
    (c) FDA may decline a De Novo request if the requester fails to
follow the requirements of this part or if, upon the basis of the
information submitted in the De Novo request or any other information
before FDA, FDA determines:
    (1) The device does not meet the criteria under section 513(a)(1)
of the Federal Food, Drug, and Cosmetic Act and Sec.  860.3 for
classification into class I or II;
    (2) The De Novo request contains a false statement of material fact
or there is a material omission;
    (3) The device's labeling does not comply with the requirements in
parts 801 and 809 of this chapter, as applicable;
    (4) The product described in the De Novo request does not meet the
definition of a device under section 201(h) of the Federal Food, Drug,
and Cosmetic Act and is not a combination product as defined at Sec.
3.2(e) of this chapter;
    (5) The device is of a type which has already been approved in
existing applications for premarket approval (PMAs) submitted under
part 814 of this chapter;
    (6) The device is of a type that has already been classified into
class I, class II, or class III;
    (7) An inspection of a relevant facility under Sec.  860.240(c)
results in a determination that general or general and special controls
would not provide reasonable assurance of safety and effectiveness;
    (8) A nonclinical study subject to part 58 of this chapter that is
described in the De Novo request, and that is essential to show there
is reasonable assurance of safety, was not conducted in compliance with
part 58 of this chapter and no reason for the noncompliance is provided
or, if a reason is provided, the practices used in conducting the study
do not support the validity of the study;
    (9) A clinical investigation described in the De Novo request
involving human subjects that is subject to the institutional review
board regulations in part 56 of this chapter, informed consent
regulations in part 50 of this chapter, or GCP described in Sec.
812.28(a) of this chapter, was not conducted in compliance with those
regulations such that the rights or safety of human subjects were not
adequately protected or the supporting data were determined to be
otherwise unreliable;
    (10) A clinical or nonclinical study necessary to demonstrate that
general controls or general and special controls provide reasonable
assurance of safety and effectiveness:
    (i) Has not been completed per the study protocol, or
    (ii) Deficiencies related to the investigation and identified in
any request for additional information under Sec.  860.240(b)(1) have
not been adequately addressed; or

    (11) After a De Novo request is accepted for review under Sec.
860.230(b), the requester makes significant unsolicited changes to the
device's:
    (i) Indications for use; or
    (ii) Technological characteristics.
    (d) An order declining a De Novo request will inform the requester
of the deficiencies in the De Novo request, including each applicable
ground for declining the De Novo request.
    (e) FDA will use the criteria specified in Sec.  860.7 to determine
the safety and effectiveness of a device in deciding whether to grant
or decline a De Novo request. FDA may use information other than that
submitted by the requester in making such determination.

    Dated: September 30, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-21677 Filed 10-4-21; 8:45 am]
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[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Page 77826]
[FR Doc No: 2022-27625]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-607-000]

K2SO, LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
K2SO, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 3, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: December 14, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-27625 Filed 12-19-22; 8:45 am]
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