[Federal Register Volume 87, Number 64 (Monday, April 4, 2022)]
[Notices]
[Page 19566]
[FR Doc No: 2022-06985]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94538; File No. SR-DTC-2021-014]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Withdrawal of a Proposed Rule Change To Provide Settlement
Services for Transactions Entered Into Under the Proposed Securities
Financing Transaction Clearing Service of the National Securities
Clearing Corporation

March 29, 2022.
    On July 22, 2021, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') proposed rule
change SR-DTC-2021-014 (``Proposed Rule Change'') pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder.\2\ The Proposed Rule Change was published for comment
in the Federal Register on August 11, 2021.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 92572 (August 5, 2021),
86 FR 44077 (August 11, 2021) (SR-DTC-2021-014).
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    On September 2, 2021, pursuant to Section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve,
disapprove, or institute proceedings to determine whether to approve or
disapprove the Proposed Rule Change.\5\ On November 5, 2021, the
Commission instituted proceedings pursuant to Section 19(b)(2)(B) of
the Act,\6\ to determine whether to approve or disapprove the Proposed
Rule Change.\7\ On February 7, 2022, pursuant to Section 19(b)(2) of
the Act,\8\ the Commission designated a longer period for Commission
action on the proceedings to determine whether to approve or disapprove
the Proposed Rule Change.\9\
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ Securities Exchange Act Release No. 92861 (September 2,
2021), 86 FR 50570 (September 9, 2021) (SR-DTC-2021-014).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ Securities Exchange Act Release No. 93533 (November 5,
2021), 86 FR 62853 (November 12, 2021) (SR-DTC-2021-014).
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ Securities Exchange Act Release No. 94167 (February 7,
2022), 87 FR 8061 (February 11, 2022) (SR-DTC-2021-014).
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    On March 25, 2022, DTC withdrew the Proposed Rule Change (SR-DTC-
2021-014).
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-06985 Filed 4-1-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Page 16279]
[FR Doc No: 2015-07019]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0191]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the upper deck of the Steel Bridge
across the Willamette River, mile 12.1, at Portland, OR. This deviation
is necessary to accommodate the annual Bridge to Brews 8K and 10K run.
This deviation allows the upper deck of the Steel Bridge to remain in
the closed-to-navigation position and need not open for marine traffic.

DATES: This deviation is effective from 8:45 a.m. until 10:40 a.m. on
April 12, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0191] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Oregon Department of Transportation
(ODOT) has requested that the upper deck of the Steel Bridge remain
closed-to-navigation to accommodate the annual Bridge to Brews 8K and
10K run. The Steel Bridge crosses the Willamette River at mile 12.1 and
is a double-deck lift bridge with a lower lift deck and an upper lift
deck which operate independent of each other. When both decks are in
the down position the bridge provides 26 feet of vertical clearance
above Columbia River Datum 0.0. When the lower deck is in the up
position the bridge provides 71 feet of vertical clearance above
Columbia River Datum 0.0. This deviation does not affect the operating
schedule of the lower deck which opens on signal. Under normal
conditions the upper deck of the Steel Bridge operates in accordance
with 33 CFR 117.897(c)(3)(ii) which states that from 8 a.m. to 5 p.m.
Monday through Friday one hour advance notice shall be given for draw
openings, and at all other times two hours advance notice shall be
given to obtain an opening. This deviation period is from 8:45 a.m.
until 10:40 a.m. on April 12, 2015. The deviation allows the upper deck
of the Steel Bridge across the Willamette River, mile 12.1, to remain
in the closed-to-navigation position and need not open for maritime
traffic from 8:45 a.m. until 10:40 a.m. on April 12, 2015.
    Vessels able to pass through the bridge in the closed positions may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation. Waterway usage on this
stretch of the Willamette River includes vessels ranging from
commercial tug and barge to small pleasure craft.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 23, 2015.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2015-07019 Filed 3-26-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 23 (Friday, February 5, 2021)]
[Notices]
[Pages 8372-8375]
[FR Doc No: 2021-02428]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2106]

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 Mapping and Insurance
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.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Colorado:
    Boulder.             City of Boulder (20-08-  The Honorable Sam Weaver, Mayor,  Planning and Development         https://msc.fema.gov/portal/          Apr. 19, 2021...........       080024
                          0969P).                  City of Boulder, 1777 Broadway    Services Department, 1739        advanceSearch.
                                                   Street, Boulder, CO 80302.        Broadway Street, Boulder, CO
                                                                                80302.
    Boulder.             Unincorporated areas of  The Honorable Deb Gardner,        Boulder County Community         https://msc.fema.gov/portal/          Apr. 19, 2021...........       080023
                          Boulder County 20-08-    Chair, Boulder County Board of    Planning and Permitting          advanceSearch.
                          0969P).                  Commissioners, P.O. Box 471,      Department, 2045 13th Street,
                                                   Boulder, CO 80306.                Boulder, CO 80302.

Connecticut: Fairfield.  Town of Stratford 20-01- The Honorable Laura R. Hoydick,   Building Department, 2725 Main   https://msc.fema.gov/portal/          Apr. 26, 2021...........       090016
                          0502P).                  Mayor, Town of Stratford, 2725    Street, Stratford, CT 06615.     advanceSearch.
                                                   Main Street, Stratford, CT
                                                   06615.
Delaware: New Castle.    Unincorporated areas of  The Honorable Matthew Meyer, New  New Castle County Land Use       https://msc.fema.gov/portal/          Apr. 15, 2021...........       105085
                          New Castle County 20-    Castle County Executive, 87       Department, 87 Read's Way, New   advanceSearch.
                          03-1274P).               Read's Way, New Castle, DE        Castle, DE 19720.
                                                   19720.
Florida:
    Lee.                 City of Bonita Springs   The Honorable Rick Steinmeyer,    Community Development            https://msc.fema.gov/portal/          Apr. 14, 2021...........       120680
                          20-04-5188P).            Mayor, City of Bonita Springs,    Department, 9220 Bonita Beach    advanceSearch.
                                                   9101 Bonita Beach Road, Bonita    Road, Bonita Springs, FL
                                                   Springs, FL 34135.                34135.
    Lee.                 City of Sanibel (20-04-  The Honorable Mick Denham,        Community Services Department,   https://msc.fema.gov/portal/          Apr. 19, 2021...........       120402
                          5855P).                  Acting Mayor, City of Sanibel,    800 Dunlop Road, Sanibel, FL     advanceSearch.
                                                   800 Dunlop Road, Sanibel, FL      33957.
                                                   33957.
    Lee.                 Unincorporated areas of  Mr. Roger Desjarlais, Lee County  Lee County Building Department,  https://msc.fema.gov/portal/          Mar. 23, 2021...........       125124
                          Lee County 20-04-        Manager, 2120 Main Street, Fort   1500 Monroe Street, Fort         advanceSearch.
                          5420P).                  Myers, FL 33901.                  Myers, FL 33901.
    Marion.              Unincorporated areas of  The Honorable Mounir Bouyounes,   Office of Marion County          https://msc.fema.gov/portal/          May 6, 2021.............       120160
                          Marion County 20-04-     Marion County Administrator,      Administrator, 601 Southeast     advanceSearch.
                          1412P).                  601 Southeast 25th Avenue,        25th Avenue, Ocala, FL 34471.
                                                   Ocala, FL 34471.
    Monroe.              City of Marathon 20-04-  The Honorable Steve Cook, Mayor,  Planning Department, 9805        https://msc.fema.gov/portal/          Apr. 5, 2021............       120681
                          5597P).                  City of Marathon, 9805 Overseas   Overseas Highway, Marathon, FL   advanceSearch.
                                                   Highway, Marathon, FL 33050.      33050.
    Monroe.              Unincorporated areas of  The Honorable Michelle Coldiron,  Monroe County Building           https://msc.fema.gov/portal/          Apr. 26, 2021...........       125129
                          Monroe County 20-04-     Mayor, Monroe County Board of     Department, 2798 Overseas        advanceSearch.
                          4391P).                  Commissioners, 25 Ships Way,      Highway, Suite 300, Marathon,
                                                   Big Pine Key, FL 33042.           FL 33050.
    Palm Beach.          City of Westlake 20-04-  The Honorable Roger Manning,      City Hall, 4001 Seminole Pratt   https://msc.fema.gov/portal/          Apr. 19, 2021...........       120018
                          3348P).                  Mayor, City of Westlake, 4001     Whitney Road, Westlake, FL       advanceSearch.
                                                   Seminole Pratt Whitney Road,      33470.
                                                   Westlake, FL 33470.
    Polk.                Unincorporated areas of  The Honorable Bill Braswell,      Polk County Land Development     https://msc.fema.gov/portal/          Apr. 15, 2021...........       120261
                          Polk County 20-04-       Chairman, Polk County Board of    Division, 330 West Church        advanceSearch.
                          0306P).                  Commissioners, P.O. Box 9005,     Street, Bartow, FL 33830.
                                                   Bartow, FL 33831.
    Coweta.              Unincorporated areas of  The Honorable Paul Poole,         Coweta County Community          https://msc.fema.gov/portal/          May 6, 2021.............       130298
                          Coweta County 21-04-     Chairman, Coweta County Board     Development Department, 22       advanceSearch.
                          0345P).                  of Commissioners, 22 East Broad   East Broad Street, Newnan, GA
                                                   Street, Newnan, GA 30263.         30263.
Maine: York.             Town of Kennebunkport    The Honorable Allen A. Daggett,   Planning and Development         https://msc.fema.gov/portal/          Apr. 19, 2021...........       230170
                          20-01-0791P).            Chairman, Town of Kennebunkport   Department, 6 Elm Street,        advanceSearch.
                                                   Board of Selectmen, 6 Elm         Kennebunkport, ME 04046.
                                                   Street, Kennebunkport, ME
                                                   04046.
Maryland: Calvert.       Unincorporated areas of  Mr. Mark Willis, Calvert County   Calvert County Services          https://msc.fema.gov/portal/          Apr. 19, 2021...........       240011
                          Calvert County 21-03-    Administrator, 175 Main Street,   Department, 150 Main Street,     advanceSearch.
                          0019P).                  Prince Frederick, MD 20678.       Suite 300, Prince Frederick,
                                                                                MD 20678.
Mississippi:
    Copiah.              City of Hazlehurst 20-   The Honorable Shirley Sandifer,   City Hall, 209 South Extension   https://msc.fema.gov/portal/          May 6, 2021.............       280046
                          04-2010P).               Mayor, City of Hazlehurst, P.O.   Street, Hazlehurst, MS 39083.    advanceSearch.
                                                   Box 549, Hazlehurst, MS 39083.

    Copiah.              Unincorporated areas of  The Honorable Ronnie Barlow,      Copiah County Courthouse, 122    https://msc.fema.gov/portal/          May 6, 2021.............       280221
                          Copiah County 20-04-     Copiah County Administrator,      South Lowe Street, Hazlehurst,   advanceSearch.
                          2010P).                  P.O. Box 551,, Hazlehurst, MS     MS 39083.
                                                   39083.
New Mexico:
    Dona Ana.            City of Las Cruces 20-   The Honorable Ken Miyagishima,    City Hall, 700 North Main        https://msc.fema.gov/portal/          Apr. 28, 2021...........       355332
                          06-1381P).               Mayor, City of Las Cruces, 700    Street, Las Cruces, NM 88001.    advanceSearch.
                                                   North Main Street, Las Cruces,
                                                   NM 88001.
    Taos.                Unincorporated areas of  Mr. Brent Jaramillo, Taos County  Taos County Planning             https://msc.fema.gov/portal/          Apr. 16, 2021...........       350078
                          Taos County 20-06-       Manager, 105 Albright Street,     Department, 105 Albright         advanceSearch.
                          2426P).                  Suite G, Taos, NM 87571.          Street, Taos, NM 87571.
North Carolina:
    Chatham.             Town of Siler City 20-   Mr. Roy Lynch, Manager, Town of   Public Works and Utilities       https://msc.fema.gov/portal/          Apr. 16, 2021...........       370058
                          04-3577P).               Siler City, P.O. Box 769, Siler   Department, 311 North 2nd        advanceSearch.
                                                   City, NC 27344.                   Avenue, Siler City, NC 27344.
    Forsyth.             City of Winston-Salem    The Honorable Allen Joines,       Inspection Department, 100 East  https://msc.fema.gov/portal/          Mar. 4, 2021............       375360
                          20-04-2834P).            Mayor, City of Winston-Salem,     1st Street, Suite 328, Winston-  advanceSearch.
                                                   P.O. Box 2511, Winston-Salem,     Salem, NC 27101.
                                                   NC 27101.
    Forsyth.             Unincorporated areas of  The Honorable David R. Plyler,    Forsyth County Planning Board    https://msc.fema.gov/portal/          Mar. 4, 2021............       375349
                          Forsyth County 20-04-    Chairman, Forsyth County Board    Office, 309 East Market Street   advanceSearch.
                          2834P).                  of Commissioners, 201 North       Winston-Salem, NC 27577.
                                                   Chestnut Street, Winston-Salem,
                                                   NC 27101.
    Chester.             Township of East         The Honorable Robert McKinstry,   Township Hall, 721 Unionville    https://msc.fema.gov/portal/          Apr. 19, 2021...........       421480
                          Marlborough 20-03-       Chairman, Township of East        Road, Kennett Square, PA         advanceSearch.
                          1170P).                  Marlborough Board of              19348.
                                                   Supervisors, 721 Unionville
                                                   Road, Kennett Square, PA 19348.
Pennsylvania:            Township of Clifton 20-  The Honorable Theodore Stout,     Township Hall, 361 State Road    https://msc.fema.gov/portal/          Apr. 6, 2021............       421751
 Lackawanna.              03-1819P).               Chairman, Township of Clifton     435, Clifton Township, PA        advanceSearch.
                                                   Board of Supervisors, 361 State   18424.
                                                   Road 435, Clifton Township, PA
                                                   18424.
Texas:
    Anderson.            Unincorporated areas of  The Honorable Robert D.           Anderson County Geographic       https://msc.fema.gov/portal/          Apr. 19, 2021...........       480001
                          Anderson County 20-06-   Johnston, Anderson County         Information Systems (GIS)        advanceSearch.
                          1140P).                  Judge, 703 North Mallard          Department, 703 North Mallard
                                                   Street, Suite 101, Palestine,     Street, Suite 109, Palestine,
                                                   TX 75801.                         TX 75801.
    Dallas.              City of Dallas 20-06-    The Honorable Eric Johnson,       Floodplain and Drainage          https://msc.fema.gov/portal/          Apr. 19, 2021...........       480171
                          2850P).                  Mayor, City of Dallas, 1500       Management Department, 320       advanceSearch.
                                                   Marilla Street, Suite 5EN,        East Jefferson Boulevard, Room
                                                   Dallas, TX 75201.                 307, Dallas, TX 75203.
    Denton.              City of Justin 20-06-    The Honorable Alan Woodall,       Department of Development        https://msc.fema.gov/portal/          Apr. 23, 2021...........       480778
                          3405P).                  Mayor, City of Justin, P.O. Box   Services, 415 North College      advanceSearch.
                                                   129, Justin, TX 76247.            Street, Justin, TX 76247.
    Denton.              City of New Fairview 20- Mr. Ben Nibarger, City of New     Geographic Information Systems   https://msc.fema.gov/portal/          Apr. 15, 2021...........       481629
                          06-2141P).               Fairview Administrator, 999       (GIS) Department, 999 Illinois   advanceSearch.
                                                   Illinois Lane, New Fairview, TX   Lane, New Fairview, TX 76078.
                                                   76078.
    Denton.              Unincorporated areas of  The Honorable Andy Eads, Denton   Denton County Development        https://msc.fema.gov/portal/          Apr. 15, 2021...........       480774
                          Denton County 20-06-     County Judge, 110 West Hickory    Services Department, 3900        advanceSearch.
                          2141P).                  Street, 2nd Floor, Denton, TX     Morse Street, Denton, TX
                                                   76201.                            76208.
    Harris.              City of Houston 21-06-   The Honorable Sylvester Turner,   Public Works and Engineering,    https://msc.fema.gov/portal/          Apr. 26, 2021...........       480296
                          0023P).                  Mayor, City of Houston, P.O.      Floodplain Management            advanceSearch.
                                                   Box 1562, Houston, TX 77251.      Department, 1002 Washington
                                                                                Avenue, 3rd Floor, Houston, TX
                                                                                77251.
    Harris.              Unincorporated areas of  The Honorable Lina Hidalgo,       Harris County Permit             https://msc.fema.gov/portal/          Apr. 26, 2021...........       480287
                          Harris County 20-06-     Harris County Judge, 1001         Department, 10555 Northwest      advanceSearch.
                          2992P).                  Preston Street, Suite 911,        Freeway, Suite 120, Houston,
                                                   Houston, TX 77002.                TX 77092.

    Tarrant.             City of Arlington 20-06- The Honorable Jeff Williams,      City Hall, 101 West Abram        https://msc.fema.gov/portal/          Apr. 19, 2021...........       485454
                          2037P).                  Mayor, City of Arlington, 101     Street, Arlington, TX 76010.     advanceSearch.
                                                   West Abram Street, Arlington,
                                                   TX 76010.
Virginia:
    Independent City.    City of Staunton 20-03-  Mr. Steven Rosenberg, City of     Community Development            https://msc.fema.gov/portal/          Mar. 30, 2021...........       510155
                          1605P).                  Staunton Manager, 116 West        Department, 116 West Beverley    advanceSearch.
                                                   Beverley Street, Staunton, VA     Street, Staunton, VA 24401.
                                                   24401.
    Loudoun.             Unincorporated areas of  Mr. Tim Hemstreet, Loudoun        Loudoun County Mapping and       https://msc.fema.gov/portal/          May 10, 2021............       510090
                          Loudoun County 20-03-    County Administrator, P.O. Box    Geographic Information (GIS)     advanceSearch.
                          1566P).                  7000, Leesburg, VA 20177.         Department, 1 Harrison Street
                                                                                Southeast, Leesburg, VA 20175.
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[FR Doc. 2021-02428 Filed 2-4-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48047-48050]
[FR Doc No: 2019-19681]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0672; Product Identifier 2019-NM-100-AD; Amendment
39-19724; AD 2019-17-04]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2019-06-
09, which applied to certain Airbus SAS Model A350-941 airplanes. AD
2019-06-09 required repetitive tightness checks of the baby bassinet
inserts installed on stowages and partitions and, depending on
findings, accomplishment of applicable corrective actions, as specified
in a European Aviation Safety Agency (EASA) AD, which was incorporated
by reference. This new AD continues to require repetitive tightness
checks of the baby bassinet inserts installed on stowages and
partitions and, depending on findings, accomplishment of applicable
corrective actions, and also requires modification of the baby bassinet
inserts, which constitutes terminating action for the repetitive
tightness checks; as specified in an EASA AD, which is incorporated by
reference. This AD was prompted by reports that baby bassinet inserts
installed on airplane stowages and partitions were found loose because
a self-securing fixation device (Loctite) had not been applied. The FAA
is issuing this AD to address the unsafe condition on these products.

DATES: This AD becomes effective September 27, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
27, 2019.
    The FAA must receive comments on this AD by October 28, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For the material incorporated by reference (IBR) in this AD,
contact the EASA, at Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0672.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0672; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued AD 2019-06-09, Amendment 39-19607 (84 FR 14602,
April 11, 2019) (``AD 2019-06-09''), which applied to certain Airbus
SAS Model A350-941 airplanes. AD 2019-06-09 was prompted by reports
that baby bassinet inserts installed on airplane stowages and
partitions were found loose because a self-securing fixation device
(Loctite) had not been applied. AD 2019-06-09 required repetitive
tightness checks of the baby bassinet inserts installed on stowages and
partitions and, depending on findings, accomplishment of applicable
corrective actions, as specified in an EASA AD, which was incorporated
by reference. The FAA issued AD 2019-06-09 to address loose baby
bassinet inserts, which, if not detected and corrected, could lead to
detachment of a baby bassinet, possibly resulting in injury to the
infant or other airplane occupants.

Actions Since AD 2019-06-09 Was Issued

    Since AD 2019-06-09 was issued, the FAA has determined that a
modification of the baby bassinet inserts installed on stowages and
partitions is necessary to address the unsafe condition.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0115, dated May 28, 2019
(``EASA AD 2019-0115'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A350-941 airplanes. The MCAI
states:

    Occurrences were reported where baby bassinet inserts installed
on Airbus A350

aeroplane stowages and on partitions were found loose. Further
investigation identified that a self-securing fixation device
(Loctite) had not been applied.
    This condition, if not detected and corrected, could lead to
detachment of a baby bassinet, possibly resulting in injury to the
infant or other aeroplane occupants.
    To address this potential unsafe condition, Airbus issued the
original issue of the AOT [Alert Operators Transmission] to provide
inspection instructions. Consequently, EASA issued AD 2018-0271
[which corresponds to FAA AD 2019-06-09] to require repetitive
tightness checks of the baby bassinet inserts installed on stowages
and partitions and, depending on findings, accomplishment of
applicable corrective action(s).
    Since that [EASA] AD was issued, Airbus and Diehl Aviation
developed the applicable [service bulletin] SB, providing
instructions for modification of the baby bassinet inserts installed
on stowages and partitions.
    For the reasons described above, this [EASA] AD retains the
requirements of EASA AD 2018-0271, which is superseded, and requires
modification of the baby bassinet inserts installed on stowages and
partitions.

Explanation of Retained Requirements

    Although this AD does not explicitly restate the requirements of AD
2019-06-09, this AD retains all requirements of AD 2019-06-09. Those
requirements are referenced in EASA AD 2019-0115, which, in turn, is
referenced in paragraph (g) of this AD.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0115 describes procedures for repetitive tightness
checks of the baby bassinet inserts installed on stowages and
partitions and, depending on findings, accomplishment of applicable
corrective actions, and modification of the baby bassinet inserts,
which terminates the repetitive tightness checks. This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section, and it is publicly available through the EASA
website.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to a bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the agency
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2019-0115 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2019-0115
is incorporated by reference in the FAA final rule. This AD, therefore,
requires compliance with the provisions specified in EASA AD 2019-0115,
through that incorporation, except for any differences identified as
exceptions in the regulatory text of this AD. Using common terms that
are the same as the heading of a particular section in the EASA AD does
not mean that operators need comply only with that section. For
example, where the AD requirement refers to ``all required actions and
compliance times,'' compliance with this AD requirement is not limited
to the section titled ``Required Action(s) and Compliance Time(s)'' in
the EASA AD. Service information specified in EASA AD 2019-0115 that is
required for compliance with EASA AD 2019-0115 is available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0672.

FAA's Justification and Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD are
unnecessary. In addition, for the reasons stated above, the FAA finds
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and the FAA did not precede it by notice and opportunity for
public comment. The FAA invites you to send any written relevant data,
views, or arguments about this AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2019-0672;
Product Identifier 2019-NM-100-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. The FAA will
consider all comments received by the closing date and may amend this
AD based on those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this AD.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, the FAA provides the following cost estimates to comply with
this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                 Action                          Labor cost            Parts cost          Cost per product
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2019-06-09....  1 work-hours x $85 per                  $0  $85.
                                          hour = $85.
New actions............................  Up to 3 work-hours x $85                $0  Up to $255.
                                          per hour = Up to $255.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
1 work-hour x $85 per hour = $85......              $0              $85
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2019-06-09, Amendment 39-19607 (84 FR 14602, April 11, 2019), and
adding the following new AD:

2019-17-04 Airbus SAS: Amendment 39-19724; Docket No. FAA-2019-0672;
Product Identifier 2019-NM-100-AD.

(a) Effective Date

    This AD becomes effective September 27, 2019.

(b) Affected ADs

    This AD replaces AD 2019-06-09, Amendment 39-19607 (84 FR 14602,
April 11, 2019) (``AD 2019-06-09'').

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 airplanes,
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2019-0115, dated May 28, 2019
(``EASA AD 2019-0115'').

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by reports that baby bassinet inserts
installed on airplane stowages and partitions were found loose
because a self-securing fixation device (Loctite) had not been
applied. The FAA is issuing this AD to address this condition,
which, if not detected and corrected, could lead to detachment of a
baby bassinet, possibly resulting in injury to the infant or other
airplane occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0115.

(h) Exceptions to EASA AD 2019-0115

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0115 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) Where EASA AD 2019-0115 specifies a date of December 26,
2018, for this AD use April 26, 2019 (the effective date of AD 2019-
06-09).
    (3) The ``Remarks'' section of EASA AD 2019-0115 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2019-0115
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0115 that contains RC procedures and
tests: Except as required by paragraph (j)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0115,
dated May 28, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0115, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this EASA AD at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. EASA AD
2019-0115 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0672.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on August 22, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-19681 Filed 9-11-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45223-45225]
[FR Doc No: 2023-14920]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6395]

Request for Applications for New Members of the Clinical Trials
Transformation Initiative/Food and Drug Administration Patient
Engagement Collaborative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for applications.

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

SUMMARY: The Food and Drug Administration (FDA or Agency), in
collaboration with the Clinical Trials Transformation Initiative
(CTTI), is requesting applications from patient advocates interested in
participating on the Patient Engagement Collaborative (PEC). The PEC is
an ongoing, collaborative forum coordinated through the FDA's Patient
Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of
the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the
patient community and FDA Staff are able to discuss an array of topics
related to increasing meaningful patient engagement with diverse
populations in medical product development and regulatory discussions
at FDA. The activities of the PEC may include, but are not limited to,
providing diverse perspectives on topics such as systematic patient
engagement, transparency, and communication; providing considerations
for implementing new strategies to enhance patient engagement at FDA;
and proposing new models of collaboration in which patient, caregiver
and patient advocate perspectives are incorporated into general medical
product development and regulatory processes.

DATES: Applications can be submitted starting at 11:59 p.m. Eastern
Time on July 14, 2023. This announcement is open to receive a maximum
of 75 applications. Applications will be accepted until 11:59 p.m.
Eastern Time on August 14, 2023 or until 75 applications are received,
whichever happens first.

ADDRESSES: All applications should be submitted to FDA's Patient
Affairs Staff in OCPP. The preferred application method is via the
online submission system provided by CTTI, available at https://duke.qualtrics.com/jfe/form/SV_6L8l7z4YfyCHFVY. For those applicants
unable to submit an application electronically, please call FDA's
Patient Affairs Staff at<PHONE_NUMBER> to arrange for mail or delivery
service submission. Only complete applications, as described under
section IV of this document, will be considered.

FOR FURTHER INFORMATION CONTACT: Wendy Slavit, Office of the
Commissioner, Office of Clinical Policy and Programs, Patient Affairs
Staff, Food and Drug Administration,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    The CTTI is a public-private partnership cofounded by FDA and Duke
University whose mission is to develop and drive adoption of practices
that will increase the quality and efficiency of clinical trials. FDA
and CTTI have long involved patients and considered patient
perspectives in their work. Furthering the engagement of diverse
patients as valued partners across the medical product research and
development continuum requires an open forum for patients and
regulators to discuss and exchange ideas.
    The PEC is an ongoing, collaborative forum in which the patient
community and FDA Staff discuss an array of topics related to
increasing patient engagement in medical product development and
regulatory discussions at FDA. The PEC is a joint endeavor between FDA
and CTTI. The activities of the PEC may inform relevant FDA and CTTI
activities. The PEC is not intended to advise or otherwise direct the
activities of either organization, and membership will not constitute
employment by either organization.
    The Food and Drug Administration Safety and Innovation Act (Pub. L.
112-144), section 1137, entitled ``Patient Participation in Medical
Product Discussions,'' added section 569C to the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c). This provision directs the
Secretary of Health and Human Services to ``develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions.'' On November 4, 2014, FDA issued a Federal
Register notice establishing a docket (FDA-2014-N-1698) for public
commenters to submit information related to FDA's implementation of
this provision. Upon review of the comments received, one common theme,
among others, included establishing an external group to provide input
on patient engagement strategies across FDA's Centers. After
considering the comments, FDA formed the PEC in 2018 to discuss a
variety of

patient engagement topics. This group is consistent with additional
legislation subsequently enacted in section 3001 of the 21st Century
Cures Act (Pub. L. 114-255) and section 605 of the FDA Reauthorization
Act of 2017 (Pub. L. 115-52), further supporting tools for fostering
patient participation in the regulatory process.
    The PEC currently has 16 members. To help ensure continuity in its
activities and organizational knowledge, the PEC maintains staggered
membership terms. During the fall of 2023, eight members will complete
a term and up to eight new members will be selected. The purpose of
this notice is to announce that the application process for up to eight
new members of the PEC is now open, and to invite and encourage
applications by the submission deadline for appropriately qualified
individuals.

II. Criteria for Membership

    The PEC includes up to 16 diverse representatives of the patient
community. Eight members from the previous application process will
remain on the PEC. The current application process is to select up to
eight new PEC members. Selected members will include the following: (1)
patients who have personal experience with a disease or medical
condition; (2) caregivers who help support a patient--parent, child,
partner, other family member, or friend--as they manage their disease
or medical condition; and/or (3) representatives of patient groups who,
through their role in the patient group, have direct or indirect
disease experience. Please note that for purposes of this activity, the
term ``caregiver'' is not intended to include individuals who are
engaged in caregiving as healthcare professionals; and the term
``patient group'' is used herein to encompass patient advocacy
organizations, disease advocacy organizations, voluntary health
agencies, nonprofit research foundations, and public health
organizations. The ultimate goal of the application and selection
process is to identify individuals who can represent patient voices for
their patient community.
    Selection criteria include the applicant's potential to
meaningfully contribute to the activities of the PEC, ability to
represent and express patient voices for their constituency, ability to
work in a constructive manner with involved stakeholders, and
understanding of the clinical research enterprise. Consideration will
also be given to ensuring the PEC includes diverse perspectives and
experiences, including but not limited to sociodemographic factors
(such as age, gender, ethnicity, and education level) and disease
experience. PEC members are required to be residents of the United
States and must be 18 years of age or older.
    Financial and other conflicts of interest will not necessarily make
applicants ineligible for membership in the PEC. However, applicants
cannot be direct employees of the medical product development industry
or a currently registered lobbyist for an FDA-regulated industry.

III. Responsibilities and Expectations

    Participation as a PEC member is voluntary. Meetings will be held
two to four times per year and will be conducted virtually with the
potential for in-person events (in the Washington, DC area).
    Reasonable accommodations will be made for members with special
needs for participation in a meeting or for any necessary travel.
Applications for PEC membership are encouraged from individuals of all
ages, sexes, genders, sexual orientations, racial and ethnic groups,
education levels, income levels, and those with and without
disabilities. Travel support will be provided, as applicable.
    To help ensure continuity in its activities and organizational
knowledge, the PEC will maintain staggered membership terms for patient
community representatives. Membership terms for new members will be 2-
year appointments, beginning January 1, 2024.
    Additional responsibilities and expectations are set forth in the
PEC Framework, which should be reviewed prior to submitting an
application, and is available at https://ctti-clinicaltrials.org/wp-content/uploads/2023/05/PEC-Framework_Revised-Apr-10-2023_FINAL.pdf.

IV. Application Process

    Any interested person may apply for membership on the PEC. To
apply, go to https://duke.qualtrics.com/jfe/form/SV_6L8l7z4YfyCHFVY.
The application is completed online and includes questions to help
determine eligibility for the PEC, demographic and other background
questions, and four brief essay questions. The brief essay questions,
to be answered in 500 characters or fewer (including spaces), are as
follows:
     Please explain why you would have an outstanding ability
to represent and express the patient voice for the disease area(s) you
selected above.
     Please give a few examples of experiences that demonstrate
your outstanding ability to work across or interact with stakeholders
in the medical product development and regulatory processes.
     Please explain how you have established an understanding
of the medical product development and regulatory processes.
     Please tell us why you are interested in becoming a member
of the PEC and how you would be able to contribute.
    Completing the application also involves submitting: (1) A current
one-page r[eacute]sum[eacute] or bio that summarizes your patient
advocacy experience and related activities (PDF format required) and
(2) a one-page letter of endorsement from a patient group (or other
similar group) with which the applicant has worked closely on
activities that are relevant to the PEC (PDF format required). Please
note, only the application and the two documents specified above will
be reviewed. Your completed application form, r[eacute]sum[eacute] or
bio, and letter of endorsement should all be submitted at the same
time.
    The r[eacute]sum[eacute] or bio must provide examples and
descriptions of relevant activities and experiences related to the
applicant's qualifications for PEC membership. The letter of
endorsement should emphasize information relevant to the criteria for
membership described above. This letter must be from and written by
someone other than yourself. The letter may address topics such as the
applicant's involvement in patient advocacy activities, experiences
that stimulated an interest in participating in discussions about
patient engagement in medical product development and regulatory
decision processes, and other information that may be helpful in
evaluating the applicant's qualifications as a potential member of the
PEC.
    Applications will be accepted until 11:59 p.m. Eastern Time on
August 14, 2023 or until 75 applications are received, whichever
happens first. Only complete applications will be considered.
    The application review period will take a minimum of 2 months after
11:59 p.m. Eastern Time on August 14, 2023.
    Additional information may be needed from some applicants during
the review period, including information relevant to understanding
potential sources of conflict of interest, in which case applicants
will be contacted directly. All applicants (both those selected for PEC
membership and those who are not selected) will be notified of the
final application decision no later than December 31, 2023.

    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14920 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P