[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Page 36392]
[FR Doc No: 2017-16461]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-912-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.204: Negotiated Rates--Bay State to BBPC 794308 & 794309 to be
effective 8/1/2017.
    Filed Date: 07/24/2017.
    Accession Number: 20170724-5047.
    Comment Date: 5:00 p.m. Eastern Time on Monday, August 07, 2017.

    Docket Numbers: RP17-914-000.
    Applicants: Bluewater Gas Storage, LLC.
    Description: Bluewater Gas Storage, LLC submits tariff filing per
154.204: Bluewater Ownership Update Filing July 2017 to be effective 6/
30/2017.
    Filed Date: 07/25/2017.
    Accession Number: 20170725-5038.
    Comment Date: 5:00 p.m. Eastern Time on Monday, August 07, 2017.

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

    Dated July 27, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-16461 Filed 8-3-17; 8:45 am]
 BILLING CODE 6717-01-P


Comment Info: =================

General Comment:As a vaper who used these products to give up cigarettes. I am appalled at the lack of scientific research done for the proposed regulations. These ecigs/epipes and ejucies are not in any way shape or form tobacco products and should not be classified as such. They are a safe alternative to conventional cigarettes. Over regulation would drive law abiding citizen underground and a black market of unregulated juices and devices would thrive.  A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.


[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Page 39643]
[FR Doc No: 2017-17547]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81400; File No. SR-NYSEArca-2017-56]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 1, To Facilitate the Listing and
Trading of Certain Series of Investment Company Units Listed Pursuant
to NYSE Arca Equities Rule 5.2(j)(3)

August 15, 2017.
    On June 19, 2017, NYSE Arca, Inc. filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to facilitate the listing and
trading of certain series of investment company units listed pursuant
to NYSE Arca Equities Rule 5.2(j)(3). The proposed rule change was
published for comment in the Federal Register on July 7, 2017.\3\ On
August 8, 2017, the Exchange filed Amendment No. 1 to the proposed rule
change.\4\ The Commission has received no comment letters on the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 81062 (June 30,
2017), 82 FR 31651.
    \4\ Amendment No. 1 is available at: https://www.sec.gov/comments/sr-nysearca-2017-56/nysearca201756.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is August 21, 2017. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change, as modified by
Amendment No. 1. Accordingly, the Commission, pursuant to Section
19(b)(2) of the Act,\6\ designates October 5, 2017, as the date by
which the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change, as modified by Amendment No. 1 (File No. SR-NYSEArca-2017-56).
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-17547 Filed 8-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Rules and Regulations]
[Page 41174]
[FR Doc No: 2017-18443]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0687]

Drawbridge Operation Regulation; St. Croix River, Stillwater, MN

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from drawbridge regulations;
request for comments.

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

SUMMARY: The Coast Guard has issued a deviation from the operating
schedule that governs the Stillwater Highway Bridge across the St.
Croix River, mile 23.4, at Stillwater, Minnesota. This deviation will
test a change to the drawbridge operation schedule to determine whether
a permanent change to the schedule is needed.

DATES: This deviation is effective without actual notice from August
30, 2017 through 11:59 p.m. October 15, 2017. For the purposes of
enforcement, actual notice will be used from 8 a.m. on August 25, 2017,
until August 30, 2017.
    Comments and related material must reach the Coast Guard on or
before November 28, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0687 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this test
deviation, call or email Eric A. Washburn, Bridge Administrator,
Western Rivers, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Stillwater Highway Bridge, across the
St. Croix River, mile 23.4, at Stillwater, Minnesota, has been modified
in its use from motorized vehicle traffic to pedestrian and bicycle use
only. The existing operation schedule of the bridge is no longer
necessary as it had been created solely to reduce the impact of
drawspan openings on motorized vehicle traffic. This test deviation
requires the bridge to open daily, every 30 minutes from 8 a.m. until
midnight, and upon two hours notice from midnight until 8 a.m. This
test deviation is effective from 8 a.m. on August 25, 2017 through
11:59 p.m. on October 15, 2017.
    The Stillwater Highway Bridge currently operates in accordance with
33 CFR 117.667(b).
    The Stillwater Highway Bridge provides a vertical clearance of 10.9
feet above normal pool in the closed-to-navigation position. Navigation
on the waterway consists primarily of commercial sightseeing/dinner
cruise boats and recreational watercraft and will not be significantly
impacted.
    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 vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.
    Documents mentioned in this notice as being available in this
docket and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

    Dated: August 25, 2017.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2017-18443 Filed 8-29-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64454-64455]
[FR Doc No: 2020-22546]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-504-000]

Northern Natural Gas Company; Notice of Schedule for
Environmental Review of the Lake City 1st Branch Line Abandonment and
Capacity Replacement Project

    On July 31, 2020, Northern Natural Gas Company (Northern) filed an
application in Docket No. CP20-504-000 requesting a Certificate of
Public Convenience and Necessity pursuant to Section 7 of the Natural
Gas Act to abandon in place and construct and operate certain natural
gas pipeline facilities. The proposed project is known as the Lake City
1st Branch Line Abandonment and Capacity Replacement Project (Project)
and would provide for safer long-term operation of Northern's system.
    On August 7, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--February 26, 2021
90-day Federal Authorization Decision Deadline--May 27, 2021

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Northern proposes the following actions in Webster and Calhoun
Counties, Iowa: (1) Abandon in-place about 34.2 miles of the Lake City
1st branch pipeline from Dayton to Lake City; (2) construct and operate
about 9.2 miles of 6-inch-diameter pipeline and associated aboveground
appurtenances (an extension of the Lake City 2nd branch line); and (3)
uprate the Maximum Allowable Operating Pressure of the existing
Callender branch pipeline, the existing Manson 2nd branch pipeline, and
25.3 miles of the existing Lake City 2nd branch pipeline.

Background

    On August 31, 2020, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Lake City 1st
Branch Line Abandonment and Capacity Replacement Project and Request
for Comments on Environmental Issues (NOI). The NOI was sent to
affected landowners; federal, state, and local government agencies;
elected officials; environmental and public interest groups; Native
American tribes; other interested parties; and local libraries and
newspapers. In response to the NOI, the Commission received comments
from three landowners and the Natural Resources Conservation Service.
The primary issues raised by the commentors are concerns regarding
federal permits and the Project's impacts on farmland and private
property. All substantive comments will be addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP20-504), and follow the
instructions. For assistance with access to eLibrary, the helpline can
be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: October 6, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-22546 Filed 10-9-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 56 (Friday, March 22, 2019)]
[Notices]
[Pages 10886-10888]
[FR Doc No: 2019-05449]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0012]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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

SUMMARY: The DOT invites public comments about our intention to request
the Office of Management and Budget (OMB) approval to reinstate an
information collection. Before a Federal agency can collect certain
information from the public, it must receive approval from OMB. Under
procedures established by the Paperwork Reduction Act of 1995, before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatement of previously approved collections.

DATES: Written comments should be submitted by May 21, 2019.

ADDRESSES: You may submit comments identified by Docket No. NHTSA-2019-
0012 through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Hisham Mohamed, NHTSA 1200 New Jersey
Ave. SE, West Building, Room W43-437, NVS-131, Washington, DC 20590.
Mr. Mohamed's telephone number is<PHONE_NUMBER>. Please identify the
relevant collection of information by referring to its OMB Control
Number.

SUPPLEMENTARY INFORMATION:
    Title: 49 CFR part 569 & 574, Compliance and Labeling of Motor
Vehicle Tires and Rims.

    OMB Control Number: 2127-0503.
    Type of Request: Reinstatement of a previously approved collection
of information.
    Abstract: The labeling of motor vehicle tires and rims with the
information required by regulations and standards benefits motor
vehicle manufacturers and consumers. Primarily, these labeling
requirements help ensure tires are mounted on appropriate rims and the
rims and tires are mounted on vehicles for which they were intended. If
tires and rims were not labeled, mismatching of tire and rim sizes
would likely occur, often resulting in poor tire performance. The
absence of the vehicle label specifying vehicle loads, axle loads, and
recommended tire inflation pressure would likely result in improper
tire selection by a tire dealer or vehicle owner. Mismatching of rims
and tires can greatly reduce the performance of tires, may cause tire
and rim failure, and may result in vehicle handling and stability
problems, which could result in loss of vehicle control.
    Federal Motor Vehicle Safety Standard (FMVSS) Nos. 109, 117, 119,
129, and 139 establish a fixed format for the labeling requirements to
be placed into or onto both sidewalls of tires manufactured for use on
motor vehicles. Each new tire manufacturer, brand name owner, and
retreader must label each tire manufactured by engraving tire and
retreaded tire molds with the appropriate labeling information.
    FMVSS Nos. 110 and 120 specify a fixed format for the placard
labeling requirements to be placed on each motor vehicle. In addition,
FMVSS Nos. 110 and 120 require additional information be labeled onto
the finished rim used on vehicles covered by this standard.
    Affected Public: New tire manufacturers, manufacturers of retreaded
tires, and manufacturers of motor vehicles.
    Frequency: Once.
    Number of Respondents: 1,800.
    The agency estimates the number of respondents to be 1,800. This
corresponds to approximately 20 new tire manufacturers and 780
manufacturers of retreaded tires, both domestically and internationally
located, that must label motor vehicle tires they manufacture in
accordance with FMVSS Nos. 109, 117, 119, 129, 139, and Regulations
Part 569 and 574. Additionally, the agency estimates approximately
1,000 manufacturers of motor vehicles (trucks, buses, automobiles,
motorcycles, and trailers), both domestically and internationally, that
must provide placard labeling for the vehicles they manufacture. NHTSA
estimates about 142,555,506 annual responses.
    Estimated Total Annual Burden Hours: 274,491.
    The estimated total annual burden of the collection of information
for new tire manufacturers, retreaders, and rim manufacturers to label
the motor vehicle tires and rims is 274,491 hours. This estimate is the
sum of the total yearly burden from Tables 1 and 2 (190,463 hours +
84,028 hours = 274,491 hours).

                                   Table 1-Burden Hours Associated With Tires
                                               [New and retreaded]
----------------------------------------------------------------------------------------------------------------
                                                                            Rate of burden/      Annual burden
                 FMVSS or regulation                    Molds per year       mold (hours)           (hours)
----------------------------------------------------------------------------------------------------------------
109/139.............................................              7,906                 5.0              39,530
117.................................................              6,117                 5.0              30,585
119/139.............................................              4,313                 5.0              21,565
129.................................................                  1                 5.0                   5
569.................................................                150                 5.0                 750
574.................................................             15,560                 6.3              98,028
                                                     -----------------------------------------------------------
    Total Yearly burden hours:......................  ..................  ..................            190,463
----------------------------------------------------------------------------------------------------------------

                                   Table 2--Burden Hours Associated With Rims
----------------------------------------------------------------------------------------------------------------
                                                                            Rate of burden/      Total annual
                        FMVSS                         Number of vehicles    vehicle (hours)     burden (hours)
----------------------------------------------------------------------------------------------------------------
110/120.............................................         19,000,000           0.0044225              84,028
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Cost: $970,620.
    The estimated total annual burden cost of the collection of
information is $970,620. This is the sum of the yearly costs in Tables
3 and 4 ($267,620 + $703,000 = $970,620).

                         Table 3--Annual Costs for Record Keepers Associated With Tires
                                               [New and retreaded]
----------------------------------------------------------------------------------------------------------------
                                   Manufacturers or
       FMVSS or regulation            retreaders        Number of molds    Cost per mold ($)  Cost per FMVSS ($)
----------------------------------------------------------------------------------------------------------------
109/139.........................                 20              10,000                  10             100,000
117.............................                 50                 500                  10               5,000
119/139.........................                780               3,000                  20              60,000
129.............................                  1                   1                 120                 120
569.............................                 20                 250                  10               2,500
574.............................                780              10,000                  10             100,000
                                 -------------------------------------------------------------------------------

    Total yearly cost:..........  ..................  ..................  ..................            267,620
----------------------------------------------------------------------------------------------------------------

                                              Table 4--Annual Costs for Record Keepers Associated With Rims
                                                                   [New and retreaded]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        FMVSS                         Number of vehicles    Number of rims      Cost per label       Cost per rim         Yearly cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
110/120.............................................         19,000,000          95,000,000             $0.0074                  NA            $703,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility, and clarity of the
information collection; and (d) ways the burden could be minimized
without reducing the quality of the collected information. The agency
will summarize and/or include your comments in the request for OMB's
clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995, 44 U.S.C.
chapter 35; and delegation of authority at 49 CFR 1.95 and 501.8.

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2019-05449 Filed 3-21-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Rules and Regulations]
[Pages 18391-18393]
[FR Doc No: 2011-7876]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0140]
RIN 1625-AA00

Safety Zone; Texas International Boat Show Power Boat Races;
Corpus Christi Marina, Corpus Christi, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
Corpus Christi, Texas for North American Tri-Hull Championship
scheduled to take place during the Texas International Boat Show. The
North American Tri-Hull Championship will consist of a series of power
boat races for approximately 8-12 vessels that are 18-feet long. The
temporary safety zone is necessary for the safety of race participants,
spectators and the general public.

DATES: The rule is effective from 7 a.m. April 8, 2011 until 8 p.m.
April 10, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0140 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0140 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LT Wes Geyer, Sector Corpus Christi
Waterways Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the dates of the event were changed
to an earlier date to eliminate the conflict with a sailing regatta
that would have presented a safety issue for participants in both
events.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Due to the need for immediate
action the restriction of vessel traffic and spectator craft is
necessary to protect life, property and the environment; therefore, a
30-day notice is impracticable. Delaying the effective date would be
contrary to the safety zone's intended objectives of protecting
participants and spectators from the known dangers associated with
power boat races.

Basis and Purpose

    This safety zone is necessary to ensure the safety of the public
and boating traffic in the Corpus Christi Marina area during this
event. This safety zone is intended to restrict vessel traffic from a
portion of the Corpus Christi Marina for short durations of time. The
size of the zone was determined by natural barriers on all four sides
of the race course and local knowledge about wind, waves, and currents
in this particular area.

Discussion of Rule

    This safety zone will encompass all waters of the Corpus Christi
Marina contained between the People's Street T-Head on the west, the
breakwater on the east, the southern boundary running from the
southernmost tip of the People's Street T-Head (approx 27N 47'43.4'', -
97W 23'16'') along a line running due east to the breakwater (approx
27N 47'43.8'', -97W 23'5.2''), and the northern boundary line running
from the northern most tip of the secondary breakwater (approx 27N
47'57'', -97W 23'21.7'') and the end of the primary breakwater (approx
27N 47'59.1'', -97 23'9.5'').
    Potential users of the waters contained in the temporary safety
zone will be notified by VHF-FM radio from the Patrol Commander and
also from a designated representative of the Captain of the Port over
the race committee's loud hailer speaker system when the

safety zone will be implemented for the 15 minutes before each race or
race heat. The same methods of notification will be used to make
notifications of the subsequent re-opening of the waters contained in
the safety zone approximately 15 minutes following the conclusion of
each race or race heat when the power boats have departed the race
course.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. It is not significant under the
regulatory policies and procedures of the Department of Homeland
Security.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation under the regulatory policies and procedures
of DHS is unnecessary.
    This determination is based upon the size and location of the
safety zone within the waterway. Vessels will only be restricted from
the safety zone for a short period of time for each race heat. Vessels
may transit through the safety zone with permission from the Captain of
the Port Corpus Christi or his designated on-scene patrol commander
between each race heat.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in the Corpus Christi Marina within the safety zone.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will only be in effect for 45-60 minutes at a time. Vessel traffic
may enter or transit through the safety zone with the permission of the
Captain of the Port Corpus Christi or his designated on-scene
representative. Before the effective period, we will issue maritime
advisories and ensure they are widely available to users of the Corpus
Christi marina.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use

voluntary consensus standards in their regulatory activities unless the
agency provides Congress, through the Office of Management and Budget,
with an explanation of why using these standards would be inconsistent
with applicable law or otherwise impractical. Voluntary consensus
standards are technical standards (e.g., specifications of materials,
performance, design, or operation; test methods; sampling procedures;
and related management systems practices) that are developed or adopted
by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishing a
temporary safety zone in the Marina of Corpus Christi, Texas.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6,
and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T08-0140 to read as follows:

Sec.  165.T08-0140  Safety Zone; Texas International Boat Show Power
Boat Races, Corpus Christi Marina, Corpus Christi, TX.

    (a) Regulated area. The following regulated area is a safety zone.
All waters of the Corpus Christi Marina contained between the People's
Street T-Head on the west, the primary breakwater on the east, the
southern boundary running from the southernmost tip of the People's
Street T-Head (approx 27N 47'43.4'', -97W 23'16'') along a line running
due east to the breakwater (approx 27N 47'43.8'', -97W 23'5.2''), and
the northern boundary line running from the northern most tip of the
secondary breakwater (approx 27N 47'57'', -97W 23'21.7'') and the end
of the primary breakwater (approx 27N 47'59.1'', -97 23'9.5'').
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, State, and local officers designated by or assisting the
Captain of the Port Corpus Christi in the enforcement of the regulated
area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port Corpus
Christi or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Corpus Christi via telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to seek permission. If
permission to enter, transit through, anchor in, or remain within the
regulated area is granted by the Captain of the Port Corpus Christi or
a designated representative, all persons and vessels receiving such
permission must comply with the instructions of the Captain of the Port
Corpus Christi or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area via
local notice to mariners, marine safety information bulletins,
broadcast notice to mariners, and by on-scene designated
representatives.
    (d) Enforcement period. The rule is effective from April 8, 2011
until April 10, 2011. The rule will be enforced daily between 7 a.m.
and 8 p.m. for the period of 15 minutes before each race or race heat
starts to a period of 15 minutes following the conclusion of each race
or race heat. Potential users of the waters contained in the safety
zone will be notified by VHF-FM radio from the Patrol Commander and
also from a designated representative of the Captain of the Port over
the race committee's loud hailer speaker system when the safety zone
will be implemented for the 15 minutes before each race or race heat.
The same methods of notification will be used to make notifications of
the subsequent re-opening of the waters contained in the safety zone
approximately 15 minutes following the conclusion of each race or race
heat when the power boats have departed the race course.
    (e) Penalties. Vessels or persons violating this rule would be
subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: March 2, 2011.
K. Moore,
Captain, U.S. Coast Guard, Alternate Captain of the Port Corpus
Christi.
[FR Doc. 2011-7876 Filed 4-1-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Notices]
[Pages 20428-20429]
[FR Doc No: 2021-07952]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34244; File No. 812-15191]

The Advisors' Inner Circle Fund, Cambiar Investors, LLC and SEI
Investments Distribution Co.

April 13, 2021.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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

    Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from sections
2(a)(32), 5(a)(1), and 22(d) of the Act and rule 22c-1 under the Act,
and under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and 17(a)(2) of the Act.

Applicants: The Advisor's Inner Circle Fund (the ``Trust''), Cambiar
Investors, LLC (the ``Initial Adviser''), and SEI Investments
Distribution Co. (the ``Distributor'').

Summary of Application: Applicants request an order (``Order'') that
permits: (a) ActiveShares ETFs (as described in the Reference Order (as
defined below)) to issue shares (``Shares'') redeemable in large
aggregations only (``creation units''); (b) secondary market
transactions in Shares to occur at negotiated market prices rather than
at net asset value; and (c) certain affiliated persons of an
ActiveShares ETF to deposit securities into, and receive securities
from, the ActiveShares ETF in connection with the purchase and
redemption of creation units. The relief in the Order would incorporate
by reference terms and conditions of the same relief of a previous
order granting the same relief sought by applicants, as that order may
be amended from time to time (``Reference Order'').\1\
---------------------------------------------------------------------------

    \1\ Precidian ETFs Trust, et al., Investment Company Act Release
Nos. 33440 (April 8, 2019) (notice) and 33477 (May 20, 2019)
(order). Applicants are not seeking relief under section 12(d)(1)(J)
of the Act for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act (the ``Section 12(d)(1) Relief''), and relief
under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and 17(a)(2) of the Act relating to the Section
12(d)(1) Relief, as granted in the Reference Order. Accordingly, to
the extent the terms and conditions of the Reference Order relate to
such relief, they are not incorporated by reference into the Order.

Filing Date: The application was filed on January 7, 2021 and amended
---------------------------------------------------------------------------
on March 30 2021.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by emailing the Commission's
Secretary at<EMAIL_ADDRESS>and serving applicants with a
copy of the request by email. Hearing requests should be received by
the Commission by 5:30 p.m. on May 10, 2021, and should be accompanied
by proof of service on applicants, in the form of an affidavit or, for
lawyers, a certificate of service. Pursuant to rule 0-5 under the Act,
hearing requests should state the nature of the writer's interest, any
facts bearing upon the desirability of a hearing on the matter, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by emailing the
Commission's Secretary at<EMAIL_ADDRESS>
ADDRESSES: The Commission<EMAIL_ADDRESS>Applicants: The
Advisors' Inner Circle Fund<EMAIL_ADDRESS>Cambiar Investors, LLC,
<EMAIL_ADDRESS>SEI Investments Distribution Co., 22686f574c414a6251474b410c414d4f;
Morgan, Lewis & Bockius LLP<EMAIL_ADDRESS>

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
at<PHONE_NUMBER> or Trace W. Rakestraw, Branch Chief, at (202) 551-
6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants

    1. The Trust is a business trust established under the laws of
Massachusetts and will consist of one or more series operating as
ActiveShares ETFs. The Trust is registered as an open-end management
investment company under the Act. Applicants seek relief with respect
to Funds (as defined below), including three initial Funds (``Initial
Funds''). The Funds will operate as ActiveShares ETFs as described in
the Reference Order.\2\
---------------------------------------------------------------------------

    \2\ To facilitate arbitrage, an ActiveShares ETF disseminates a
``verified intraday indicative value'' or ``VIIV,'' reflecting the
value of its portfolio holdings, calculated every second during the
trading day. To protect the identity and weightings of its portfolio
holdings, an ActiveShares ETF sells and redeems its Shares in
creation units to authorized participants only through an
unaffiliated broker-dealer acting on an agency basis.
---------------------------------------------------------------------------

    2. The Initial Adviser, a Delaware limited liability company, will
be the investment adviser to the Initial Funds. An Adviser (as defined
below) will serve as investment adviser to each Fund. The Initial
Adviser is, and any other Adviser will be, registered as an investment
adviser under the Investment Advisers Act of 1940 (``Advisers Act'').
The Adviser may enter into sub-advisory agreements with other
investment advisers to act as sub-advisers with respect to the Funds
(each a ``Sub-Adviser''). Any Sub-Adviser will be registered under the
Advisers Act.
    3. The Distributor is a Pennsylvania corporation and a broker-
dealer registered under the Securities Exchange Act of 1934, as
amended, and will act as the principal underwriter of Shares of the
Funds. Applicants request that the requested relief apply to any
distributor of Shares, whether affiliated or unaffiliated with the
Adviser and/or Sub-Adviser (included in the term ``Distributor''). Any
Distributor will comply with the terms and conditions of the Order.

Applicants' Requested Exemptive Relief

    4. Applicants seek the requested Order under section 6(c) of the
Act for an exemption from sections 2(a)(32), 5(a)(1), and 22(d) of the
Act and rule 22c-1 under the Act, and under sections 6(c) and 17(b) of
the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the
Act. The requested Order would permit applicants to offer ActiveShares
ETFs. Because the relief requested is the same as certain of the relief
granted by the Commission under the Reference Order and because the
Initial Adviser has entered into a license agreement with Precidian
Investments LLC, or an affiliate thereof, in order to offer
ActiveShares ETFs,\3\ the Order would incorporate by reference the
terms and conditions of the same relief of the Reference Order.
---------------------------------------------------------------------------

    \3\ Aspects of the Funds are covered by intellectual property
rights, including but not limited to those which are described in
one or more patent applications.
---------------------------------------------------------------------------

    5. Applicants request that the Order apply to the Initial Funds and
to any other existing or future registered open-end management
investment company or series thereof that: (a) Is advised by the
Initial Adviser or any entity controlling, controlled by, or under
common control with the Initial Adviser (any such entity, along with
the Initial Adviser, included in the term ``Adviser''); (b) operates as
an ActiveShares ETF as described in the Reference Order; and (c)
complies with the terms and conditions of the Order and the terms and
conditions of the Reference Order that are incorporated by reference
into the Order (each such company or series and each Initial Fund, a
``Fund'').\4\
---------------------------------------------------------------------------

    \4\ All entities that currently intend to rely on the Order are
named as applicants. Any other entity that relies on the Order in
the future will comply with the terms and conditions of the Order
and the terms and conditions of the Reference Order that are
incorporated by reference into the Order.
---------------------------------------------------------------------------

    6. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any class of persons,
securities or transactions, from any provisions of the Act, if and to
the extent that such exemption is necessary or appropriate in the
public interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act.
Section 17(b) of the Act authorizes the Commission to exempt a proposed
transaction from section 17(a) of the Act if evidence establishes that
the terms of the transaction, including the consideration to be paid or
received, are reasonable and fair and do not involve overreaching on
the part of any person concerned, and the transaction is consistent
with the policies of the registered investment company and the general
purposes of the Act. Applicants submit that for the reasons stated in
the Reference Order the requested relief meets the exemptive standards
under sections 6(c) and 17(b) of the Act.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-07952 Filed 4-16-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 2, 2008 (Volume 73, Number 192)]
[Rules and Regulations]
[Page 57237-57238]
[DOCID:fr02oc08-4]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 229

[Release Nos. 33-8961; 34-58656]

Technical Amendment to Item 407 of Regulation S-K

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Securities and Exchange Commission (``Commission'') is
making a technical amendment to Item 407 of Regulation S-K. The
technical amendment updates a reference to Independence Standards Board
Standard No. 1 (``ISB No. 1''), which was previously adopted by the
Public Company Accounting Oversight Board (``PCAOB'') as an interim
standard but has been superseded by the PCAOB's newly adopted Ethics
and Independence Rule 3526, Communication with Audit Committees
Concerning Independence. The reference is being updated to refer to the
``applicable requirements of the Public Company Accounting Oversight
Board regarding the independent accountant's communications with the
audit committee concerning independence.''

DATES: Effective Date: September 30, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie Jacobsen, Special Counsel, at
202-551-5300, Office of the Chief Accountant, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549-5041.

SUPPLEMENTARY INFORMATION:

I. Background

    We are amending Item 407 of Regulation S-K \1\ to update a
reference as a result of the adoption of a new Public Company
Accounting Oversight Board (``PCAOB'') rule. Item 407 is being amended
to update the following reference:
---------------------------------------------------------------------------

    \1\ 17 CFR 229.407.
---------------------------------------------------------------------------

    Old Reference:
    ``Independence Standards Board Standard No. 1 (Independence
Standards Board Standard No. 1, Independence Discussions with Audit
Committees), as adopted by the Public Company Accounting Oversight
Board in Rule 3600T''
    New Reference:
    ``applicable requirements of the Public Company Accounting
Oversight Board regarding the independent accountant's communications
with the audit committee concerning independence''
    Independence Standards Board Standard No. 1 (``ISB No. 1'') was
part of the interim standards previously adopted by the PCAOB on April
16, 2003.\2\ It required an auditor annually to discuss with the audit
committee its independence and to provide written disclosures of all
relationships between the auditor and the company that may reasonably
be thought to bear on independence and a letter confirming the
auditor's independence.\3\
---------------------------------------------------------------------------

    \2\ PCAOB Rule 3600T.
    \3\ ISB No. 1.
---------------------------------------------------------------------------

    Effective on September 30, 2008, PCAOB Rule 3526 supersedes ISB No.
1 regarding the annual discussion and disclosure the auditor must make
to the audit committee.\4\ Rule 3526 was adopted by the PCAOB on April
22,

2008 and approved by the Commission on August 22, 2008.
---------------------------------------------------------------------------

    \4\ Rule 3526 also superseded ISB Interpretation 00-1, The
Applicability of ISB Standard No. 1 When ``Secondary Auditors'' are
Involved in the Audit of a Registrant, and ISB Interpretation 00-2,
The Applicability of ISB Standard No. 1 When ``Secondary Auditors''
Are Involved in the Audit of a Registrant, An Amendment of
Interpretation 00-1.
---------------------------------------------------------------------------

    Under existing Item 407 of Regulation S-K, an issuer's audit
committee must state that it has received from the independent
accountants the written disclosures and letter required by ISB No. 1.
As revised, Item 407 requires the audit committee to state that it has
received the disclosure and letter required by the applicable PCAOB
requirements for independent accountant communications with audit
committees concerning auditor independence because ISB No. 1 has been
superseded by PCAOB Rule 3526. To avoid the need to update a specific
reference in the future if subsequently changed, we are revising the
reference in Item 407 Regulation S-K so that it refers to the written
disclosures and the letter from the independent accountants required by
``applicable requirements of the Public Company Accounting Oversight
Board regarding the independent accountant's communications with the
audit committee concerning independence.''
    We are not revising Item 407 of Regulation S-B in the same manner
as we are revising Item 407 of Regulation S-K due to amendments that we
made in December 2007 to expand the number of smaller reporting
companies that qualify for our scaled disclosure requirements under the
Securities Act and the Securities Exchange Act of 1934.\5\ To
streamline and simplify regulation, the amendments moved the scaled
disclosure requirements from Regulation S-B into Regulation S-K. While
Regulation S-B will remain in effect for transition purposes until
March 15, 2009, it will be removed from the Code of Federal Regulations
in its entirety after that date. We therefore are not revising
Regulation S-B, but we intend to interpret existing Regulation S-B Item
407 consistently with the technical changes that we are making to the
comparable Regulation S-K item. Accordingly, we expect companies
complying with Regulation S-B after the effective date of these
amendments, but before March 15, 2009, to follow the applicable PCAOB
requirements for independent accountant auditor independence.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78a et seq.
---------------------------------------------------------------------------

II. Certain Findings

    Under the Administrative Procedure Act, a notice of proposed
rulemaking is not required when the agency, for good cause, finds that
notice and public comment are impracticable, unnecessary, or contrary
to the public interest.\6\ The amendment to Item 407 of Regulation S-K
is a technical change to update an outdated reference. Because no one
is likely to want to comment on such a non-substantive, technical
amendment, the Commission finds that it is unnecessary to publish
notice of this amendment.\7\
---------------------------------------------------------------------------

    \6\ 5 U.S.C. 553(b).
    \7\ For similar reasons, the amendment does not require analysis
under the Regulatory Flexibility Act or analysis of major rule
status under the Small Business Regulatory Enforcement Fairness Act.
See 5 U.S.C. 601(2) (for purposes of Regulatory Flexibility Act
analysis, the term ``rule'' means any rule for which the agency
publishes a general notice of proposed rulemaking); and 5 U.S.C.
804(3)(C) (for purposes of Congressional review of agency
rulemaking, the term ``rule'' does not include any rule of agency
organization, procedure or practice that does not substantially
affect the rights or obligations of non-agency parties).
---------------------------------------------------------------------------

    The Administrative Procedure Act also requires publication of a
rule at least 30 days before its effective date unless the agency finds
otherwise for good cause.\8\ Due to the need to coordinate the
effectiveness of the amendment with the effective date of the PCAOB's
new Rule 3526 (which is to take effect on September 30, 2008) and for
the same reasons described with respect to opportunity for notice and
comment, the Commission finds there is good cause for the amendments to
take effect on September 30, 2008.
---------------------------------------------------------------------------

    \8\ See 5 U.S.C. 553(d)(3).
---------------------------------------------------------------------------

III. Consideration of Competitive Effects of Amendment

    Section 23(a)(2) of the Exchange Act requires the Commission, in
adopting rules under the Exchange Act, to consider the competitive
effects of such rules, if any, and to refrain from adopting a rule that
would impose a burden on competition not necessary or appropriate in
furtherance of the purposes of the Exchange Act.\9\ Because this
amendment merely makes technical changes to update references to
applicable PCAOB requirements, we do not anticipate any competitive
advantages or disadvantages would be created.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78w(a)(2).
---------------------------------------------------------------------------

IV. Statutory Authority and Text of Amendments

    We are adopting this technical amendment under the authority set
forth in Section 19(a) of the Securities Act \10\ and Section 23(a) of
the Exchange Act.\11 \
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 77s(a).
    \11\ 15 U.S.C. 78w(a).
---------------------------------------------------------------------------

List of Subjects in 17 CFR Part 229

    Reporting and recordkeeping requirements, Securities.

Text of Amendments

0
For the reasons set out in the preamble, Title 17, Chapter II of the
Code of the Federal Regulations is amended as follows:

PART 229--STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES
ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND
CONSERVATION ACT OF 1975--REGULATION S-K

0
1. The authority citation for part 229 continues to read in part as
follows:

    Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s, 77z-2,
77z-3, 77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj,
77nnn, 77sss, 78c, 78i, 78j, 78l, 78m, 78n, 78o, 78u-5, 78w, 78ll,
78mm, 80a-8, 80a-9, 80a-20, 80a-29, 80a-30, 80a-31(c), 80a-37, 80a-
38(a), 80(a)-39, 80b-11, and 7201 et seq.; and 18 U.S.C. 1350,
unless otherwise noted.
* * * * *

0
2. Section 229.407 is amended by revising paragraph (d)(3)(i)(C) to
read as follows:

Sec.  229.407 (Item 407)  Corporate governance.

* * * * *
    (d) * * *
    (3) * * *
    (i) * * *
    (C) The audit committee has received the written disclosures and
the letter from the independent accountant required by applicable
requirements of the Public Company Accounting Oversight Board regarding
the independent accountant's communications with the audit committee
concerning independence, and has discussed with the independent
accountant the independent accountant's independence; and
* * * * *

    By the Commission.

    Dated: September 26, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-23057 Filed 9-30-08; 11:15 am]

BILLING CODE 8011-01-P


[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Notices]
[Page 41283]
[DOCID:fr20jy06-92]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review, Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 17a-8; SEC File No. 270-53; OMB Control No. 3235-
0092.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget requests for extension of the previously approved collection
of information discussed below.

Rule 17a-8--Financial Recordkeeping and Reporting of Currency and
Foreign Transactions

    Rule 17a-8 (17 CFR 240.17a-8) under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.) (the ``Act'') requires brokers and dealers
to make and keep certain reports and records concerning their currency
and monetary instrument transactions. The requirements allow the
Commission to ensure that brokers and dealers are in compliance with
the Currency and Foreign Transactions Reporting Act of 1970 (``Bank
Secrecy Act'') and with the Department of the Treasury regulations
under that Act.
    The reports and records required under this rule initially are
required under Department of the Treasury regulations, and additional
burden hours and costs are not imposed by this 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 control number.
    Comments should be directed to (1) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC, 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (2) R. Corey Booth, Director/Chief Information

Officer, Securities and Exchange Commission, C/O Shirley Martinson,
6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

     Dated: June 29, 2006.
 J. Lynn Taylor,
 Assistant Secretary.
 [FR Doc. E6-11499 Filed 7-19-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Rules and Regulations]
[Pages 60732-60733]
[FR Doc No: 2011-25177]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0625]

Drawbridge Operation Regulations; Navesink (Swimming) River, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Oceanic Bridge at mile 4.5 across the Navesink (Swimming) River between
Oceanic and Locust Point, New Jersey. The deviation is necessary to
facilitate bridge rehabilitation. This deviation allows the bridge to
open only one of the two moveable spans for the passage of vessel
traffic.

DATES: This deviation is effective from October 31, 2011 through April
27, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0625 and are available online
at http://www.regulations.gov, inserting USCG-2011-0625 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Joe Arca, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>or telephone<PHONE_NUMBER>. If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Oceanic Bridge, across the Navesink
(Swimming) River, mile 4.5, between Oceanic and Locust Point, New
Jersey, has a vertical clearance in the closed position of 22 feet at
mean high water and 24 feet at mean low water. The drawbridge operation
regulations are listed at 33 CFR 117.734.
    The vessel traffic that normally transits the bridge are seasonal
recreational vessels.
    The owner of the bridge, County of Monmouth New Jersey, requested a
temporary deviation from the regulations to facilitate bridge
rehabilitation repairs. During the bridge repairs only one moveable
span can be opened for the passage of vessel traffic.
    The navigation channel under the bridge provides 75 feet of
horizontal clearance with unobstructed vertical clearance in the open
position.
    During this temporary deviation the horizontal clearance in the
main channel will provide 37.5 feet of horizontal clearance keeping one
moveable span in the closed position.
    The Coast Guard believes that this temporary deviation meets the
reasonable needs of navigation because the recreational users that
normally use this bridge do not operate during the winter months when
this deviation will be in effect and the 37.5 feet of horizontal
clearance should be sufficient for the seasonal recreational vessel
traffic that uses this waterway.
    Under this temporary deviation the Oceanic Bridge may open only one
of the two moveable spans for the passage of vessel traffic between
October 31, 2011 and April 27, 2012.
    Vessels that can pass under the bridge in the closed position may
do so at any time.
    In accordance with 33 CFR 117.35(e), the bridge 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: September 19, 2011.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2011-25177 Filed 9-29-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Pages 52685-52689]
[FR Doc No: 2021-20432]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3326]

Reauthorization of the Biosimilar User Fee Act; Public Meeting;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is hosting a
virtual public meeting to discuss proposed recommendations for the
reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years
(FYs) 2023 through 2027. The BsUFA authorizes FDA to collect user fees
to support the process for the review of biosimilar biological product
applications. The current legislative authority for BsUFA expires in
September 2022. At that time, new legislation will be required for FDA
to continue collecting user fees in future fiscal years. Following
discussions with the regulated industry and consultations with public
stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act)
directs FDA to publish the recommendations for the reauthorized program
in the Federal Register, hold a meeting at which the public may present
its views on such recommendations, and provide for a period of 30 days
for the public to provide written comments on such recommendations. FDA
will then consider such public views and comments and revise such
recommendations, as necessary.

DATES: The public meeting will be held on November 2, 2021, from 9 a.m.
to 12 p.m. Eastern Time, and will be held by webcast only. Submit
either electronic or written comments on this public

meeting by December 2, 2021. See SUPPLEMENTARY INFORMATION for
registration date and information.

ADDRESSES: Registration to attend the meeting and other information can
be found at https://bsufaiii-finalpublicmeeting.eventbrite.com.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 2, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 2, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-3326 for ``Reauthorization of the Biosimilar User Fee Act;
Public Meeting; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Emily Ewing, Center for Drug
Evaluation and Research, Food and Drug Administration,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a virtual public meeting to discuss proposed
recommendations for the reauthorization of BsUFA, the legislation that
authorizes FDA to collect user fees to support the process for the
review of biosimilar biological product applications. The current
authorization of the program (BsUFA II) expires in September 2022.
Without new legislation, FDA will no longer be able to collect user
fees for future FYs to fund the process for the review of biosimilar
biological product applications. Section 744I(f)(2) of the FD&C Act (21
U.S.C. 379j-53(f)(2)) requires the Agency perform the following actions
after holding negotiations with regulated industry members: (1) Present
recommendations to the relevant Congressional committees; (2) publish
recommendations in the Federal Register, (3) provide a period of 30
days for the public to provide written comments on the recommendations;
(4) hold a meeting at which the public may present its views; and (5)
after consideration of public views and comments, revise the
recommendations as necessary.
    This notice, the 30-day comment period, and the public meeting will
satisfy some of these requirements. After the public meeting, we will
revise the recommendations as necessary and present our proposed
recommendations to the Congressional committees.
    The purpose of the meeting is to hear the public's views on the
proposed recommendations for the reauthorized program (BsUFA III). The
following information is provided to help potential meeting
participants better understand the history and evolution of the BsUFA
program and the status of the proposed BsUFA III recommendations.

II. What is BsUFA and what does it do?

    BsUFA is a law that authorizes FDA to assess and collect fees from
drug companies that submit marketing applications for certain
biosimilar biological products. BsUFA was originally enacted in 2012 as
the Biosimilar User Fee Act under the Food and Drug Administration
Safety and Innovation Act (FDASIA, Pub. L. 112-144) for a period of 5
years. In 2017, BsUFA was renewed for 5 more years under the FDA
Reauthorization Act of 2017 (FDARA, Pub. L. 115-52).
    BsUFA is intended to provide additional revenues so that FDA can
hire staff, improve systems, and continue a well-managed biosimilar

biological product review process to make biosimilar biological product
therapies available to patients sooner without compromising review
quality or FDA's high standards for safety, efficacy, and quality. As
part of FDA's agreements with industry during prior BsUFA
authorizations, the Agency agreed to certain performance and procedural
goals and other commitments. These goals apply to the process for the
review of biosimilar biological product applications, including
biosimilar biological product development meetings, review of
applications and supplements, and other review activities. FDA's web
page ``Biosimilar User Fee Amendments'' provides more information about
BsUFA, including the statutory text of FDARA, the BsUFA commitment
letter, ``Biosimilar Authorization Performance Goals and Procedures
Fiscal Years 2013 through 2017'' (BsUFA Commitment Letter), key Federal
Register documents, BsUFA-related guidances, BsUFA user fee rates,
performance reports, and financial reports. The Agency's ``Biosimilar
User Fee Amendments'' web page is available at https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments.
    With the current authorization of BsUFA II under FDARA, FDA
implemented a review program (``the Program'') to promote the
efficiency and effectiveness of the first cycle review process. The
Program allows for additional communication between the FDA review team
and applicants of biosimilar biological products, including mid-cycle
communications and late-cycle meetings, while adding 60 days to the
review clock to provide for this increased interaction and to address
review issues. BsUFA II also includes commitments to advance
development of biosimilar biological products through further
clarification of the regulatory pathway that permits a biosimilar
biological product to be licensed under section 351(k) of the Public
Health Service Act, and to enhance capacity for biosimilar guidance
development, reviewer training, and timely communication. More
information on these commitments can be found in the BsUFA II
Commitment Letter at https://www.fda.gov/media/100573/download.
    As part of the current authorization, FDA established an
independent fee structure and fee amounts to improve program funding
predictability, stability, and administrative efficiency. The new
structure established a BsUFA target revenue based on BsUFA program
costs and updated the overall fee structure and related financial
mechanisms. The agreement also included commitments to enhance
management of user fee resources through the development of a resource
capacity planning capability and third-party evaluation of program
resource management, management of the carryover balance, along with
the publication and annual update of a 5-year financial plan.
    The current authorization also includes several commitments to
improve the hiring and retention of critical review staff through
modernization of FDA's hiring system, augmentation of hiring staff
capacity and capabilities, creation of a dedicated function focused on
staffing the program, reporting on hiring metrics, and a comprehensive
and continuous assessment of hiring and retention. A list of the
deliverables developed to meet BsUFA II commitments is available on the
FDA web page https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-ii-deliverables.

III. Proposed BsUFA III Recommendations

    In preparing the proposed recommendations to Congress for BsUFA
reauthorization, FDA conducted discussions with regulated industry
members, as required by the law. We began the BsUFA reauthorization
process by publishing a notice in the Federal Register requesting
public input on the reauthorization and announcing a public meeting
that was held on November 19, 2020. The meeting included presentations
by FDA and a series of panels with representatives of different
stakeholder groups, including patient advocates, consumer groups,
regulated industry members, health professionals, and academic
researchers. The materials from the meeting, including a transcript and
webcast recording, can be found at https://www.fda.gov/industry/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020.
    Following the November 2020 public meeting, FDA conducted
negotiations with regulated industry from March 2021 through June 2021.
As directed by Congress, FDA posted minutes of these meetings on its
web page at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027.
    The proposed enhancements for BsUFA III address many of the top
priorities identified by public stakeholders, regulated industry, and
FDA. While some of the proposed enhancements are new, many either build
on successful enhancements or refine elements from the existing
program. The enhancements are proposed in the following areas:
Supplemental applications, meeting management, best practices in
communication between FDA and sponsors, inspections and alternative
tools, interchangeable biosimilar biological product development,
regulatory science, finance, hiring and retention, and information
technology. The full text of the proposed BsUFA III Commitment Letter
can be found on the Agency's web page ``BsUFA III: Fiscal Years 2023--
2027,'' available at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027. Each significant new or
modified enhancement is described briefly below:

A. Original and Resubmitted Supplemental Biosimilar Biological Product
Applications

    To expedite the review of supplemental biosimilar biological
product applications, FDA proposes to establish new supplement
categories, timelines, and performance goals. New review timelines
range from 3 to 10 months, depending on the content and category of the
supplement submission. Certain supplements for safety labeling updates
and labeling updates to add or remove an indication that do not contain
efficacy data sets would have shorter review timelines than supplements
in other categories. These enhancements are described in section I.A.2
of the proposed BsUFA III Commitment Letter.

B. Meeting Management Goals

    To improve overall meeting management, FDA proposes to modify the
Biosimilar Initial Advisory (BIA) meeting, create a new Type 2a
meeting, and modify the timing of Type 4 meeting background packages.
FDA would not require the submission of preliminary comparative
analytical data for a BIA meeting. The new Type 2a meeting would allow
for quicker discussion on a narrow set of issues (e.g., often one but
no more than two issues) involving no more than three review
disciplines or divisions. Traditional Type 2 meetings under BsUFA II
would be renamed to Type 2b meetings in BsUFA III. Under this proposal,
the Type 4 meeting background package may be submitted up to 14
calendar days after FDA receives the meeting request. There would also
be a new followup opportunity to pose clarifying questions after
meetings or a written-response-

only communication. These enhancements are described in section I.H of
the proposed BsUFA III Commitment Letter.

C. Promoting Best Practices in Communication Between FDA and Sponsors
During Application Review

    To enhance communication with sponsors during biosimilar biologic
product application review, FDA proposes to update relevant guidances,
our Manual of Policies and Procedures, and our Standard Operating
Procedures and Policies regarding best practices in communication. FDA
would utilize lessons learned from BsUFA II to update the relevant
documents, as appropriate. The details of this enhancement are found in
section II.A of the proposed BsUFA III Commitment Letter.

D. Enhancing Inspection Communication and Alternative Tools

    To facilitate the timely development of biosimilar biological
products and their availability to patients, FDA proposes to notify
sponsors of certain pre-license inspections and to issue guidance on
FDA's thinking on the use of alternative tools to assess manufacturing
facilities beyond the COVID-19 pandemic. These enhancements are
described in section II.B of the proposed BsUFA III Commitment Letter.

E. Advancing Development of Biosimilar Biological-Device Combination
Products Regulated by CDER and CBER

    Sponsors employ Use-Related Risk Analyses (URRA) studies to
identify the need for risk mitigation strategies and to design a human
factors (HF) validation study. Based on a URRA, a sponsor may propose
that a HF validation study is not needed to support the safe and
effective use of a biosimilar biologic-device combination product. FDA
proposes establishing new procedures for the review of URRAs along with
performance goals. Human factors studies are conducted to evaluate the
user interface of a biosimilar biologic-device combination product to
eliminate or mitigate use-related hazards that may affect the safe and
effective use of the combination product. Over the past decade, more
combination products have been developed to deliver therapeutics via
different routes of administration (e.g., parenteral, inhalation) with
complex engineering designs. HF validation protocols are reviewed
during the investigational new drug application stage with the goal
towards developing a final finished combination product that supports
the marketing application. To achieve this objective, FDA proposes
updating the procedures for HF validation study protocols, along with a
new performance goal. These enhancements are described in section II.C
of the proposed BsUFA III Commitment Letter.

F. Advancing Development of Interchangeable Biosimilar Biological
Products

    FDA proposes a focused effort in BsUFA III to further advance the
development of safe and effective interchangeable biosimilar biological
products. This effort would address current needs, prospectively
identify future needs, and incorporate the following components: (1)
Research leveraging the BsUFA III Regulatory Science Pilot Program; (2)
foundational guidance development; and (3) stakeholder engagement
involving a scientific workshop on the development of interchangeable
biosimilar biological products to help identify future needs.
Associated with this workshop, FDA would issue draft and final strategy
documents outlining FDA's actions to facilitate the development of
interchangeable biosimilar biological products. The details of this
enhancement are described in section II.D of the proposed BsUFA III
Commitment Letter.

G. Regulatory Science

    To enhance regulatory decision-making and facilitate science-based
recommendations in areas foundational to biosimilar biological product
development, FDA proposes to pilot a regulatory science program broadly
applicable to biosimilar and interchangeable biological product
development, with project goals not specific to a product or product
class. The pilot program would focus on two demonstration projects: (1)
Advancing the development of interchangeable biosimilar biological
products and (2) improving the efficiency of biosimilar biological
product development. As part of these demonstration projects, FDA
proposes to engage stakeholders in a public meeting to review the
progress of the demonstration projects and to solicit input of future
priorities. An interim report would be issued prior to the public
meeting, and a final summary report of outcomes from the pilot program
would be posted on FDA's website. Within 12 months of completing the
demonstration projects, FDA would publish a comprehensive strategy
document outlining actions FDA will take to facilitate the development
of biosimilar and interchangeable biological products. These
enhancements are described in section II.E of the proposed BsUFA III
Commitment Letter.

H. Continued Enhancement of User Fee Resource Management

    FDA is committed to ensuring the sustainability of BsUFA program
resources and to enhancing the operational agility of the BsUFA
program. FDA proposes to build on the financial enhancements included
in BsUFA II and continue activities in BsUFA III to ensure optimal use
of user fee resources and the alignment of staff to workload through
the continued maturation and assessment of the Agency's resource
capacity planning capability. This proposal would also include an
independent assessment of the resource capacity planning capability.
FDA proposes to continue activities to promote transparency of the use
of financial resources in support of the BsUFA program through annual
public meetings, publishing a 5-year financial plan along with annual
updates, and additional reporting in the annual BsUFA Financial Report.
These enhancements are described in section III of the proposed BsUFA
III Commitment Letter.

I. Information Technology

    FDA proposes to establish and progress a data and technology
modernization strategy that provides FDA's strategic direction for
current and future state data-driven regulatory initiatives.
Additionally, FDA would advance the use of cloud-based technology to
modernize the Electronic Submission Gateway to support greater data
submission bandwidth and storage in the BsUFA program. These
enhancements are described in section V of the proposed BsUFA III
Commitment Letter.

J. Enhancements to Fee Mechanisms for Increased Predictability,
Stability, and Efficiency

    The proposed BsUFA III agreement continues to build on the resource
capacity planning capability established in BsUFA II and continues
financial transparency initiatives. In addition, to manage financial
risks in the program, BsUFA III proposes to enhance the operating
reserve adjustment mechanism to provide for a defined minimum and
maximum required amount of operating reserves. The proposed minimum
amount is equivalent to 10 weeks of operating reserves and the maximum
amount is equivalent to 21 weeks of available operating reserves to be
maintained each year. The annual maximum

amount of available operating reserves would be phased in over the
first 3 years of BsUFA III (33 weeks in fiscal year 2023, 27 weeks in
fiscal year 2024, and 21 weeks in fiscal year 2025). BsUFA III also
proposes to add a strategic hiring and retention adjustment to ensure
FDA has the funding necessary to provide for the costs of retaining and
hiring highly qualified scientific and technical staff for the process
for the review of biosimilar biological product applications under
BsUFA. This strategic hiring and retention adjustment would add
$150,000 to the base revenue amount each fiscal year during BsUFA III.

K. Impact of BsUFA III Enhancements on User Fee Revenue

    To implement the proposed enhancements for BsUFA III, funding for a
cumulative total of 15 FTE staff is proposed to be phased in over the
course of BsUFA III. The new funding would be phased in as follows:

 $4,428,886 for fiscal year 2023
 $320,569 for fiscal year 2024

IV. Public Meeting Information

A. Purpose and Scope of the Meeting

    The virtual public meeting will include a presentation by FDA and
an industry panel. For members of the public who would like to make
verbal comments on the proposed enhancements, there will be a public
comment period at the end of the meeting (see instructions below). We
will also provide an opportunity for individuals to submit written
comments to the docket before and after the meeting.

B. Participating in the Public Meeting

    Registration: Registration is optional and not required to attend
this virtual public meeting. However, registering will allow FDA to
provide you with email updates if any meeting details change. If you
wish to register, you can do so at https://bsufaiii-finalpublicmeeting.eventbrite.com.
    Opportunity for Verbal Public Comment: Those who register online
will receive a confirmation email that includes a link to a request
form to make a verbal public comment at the meeting. If you wish to
speak during the public comment session, follow the instructions in the
notification and identify which topic(s) you wish to address. We will
do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time jointly. All
requests to make a public comment during the meeting must be received
by October 19, 2021, 11:59 p.m. Eastern Time. Depending on the number
of requests, we will determine the amount of time allotted to each
commenter, the approximate time each comment is to begin, and will
select and notify participants by October 26, 2021. No commercial or
promotional material will be permitted to be presented at the public
meeting.
    Streaming Webcast of the Public Meeting: The Zoom Webinar ID for
this public meeting is<PHONE_NUMBER>. The webcast link for this public
meeting can be found here: https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09. The link above should
allow you to enter the webinar directly. If Zoom asks for a passcode,
please use the case-sensitive passcode below.
Case-Sensitive Passcode for Zoom Webinar: S9d&fx
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). Transcripts of the meeting will be available on the
FDA web page https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 approximately 30 days after
the meeting.

    Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20432 Filed 9-21-21; 8:45 am]
BILLING CODE 4164-01-P