[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Rules and Regulations]
[Page 61980-61982]
[DOCID:fr07oc10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0610; Directorate Identifier 2009-SW-47-AD;
Amendment 39-16455; AD 2010-20-20]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Model SA-365N, SA-
365N1, AS-365N2, AS-365N3, SA-366G1, EC 155B, EC155B1, SA-365C, SA-
365C1, SA-365C2, SA-360C Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule.

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SUMMARY: This amendment supersedes an existing airworthiness directive
(AD) for the specified Eurocopter France (Eurocopter) helicopters. That
AD requires repetitively inspecting the main gearbox (MGB) planet gear
carrier for a crack and replacing any MGB that has a cracked planet
gear carrier before further flight. This action requires the same
inspections required by the existing AD, but shortens the initial
inspection interval. This AD is prompted by the discovery of another
crack in a MGB planet gear carrier and additional analysis that
indicates that the initial inspection interval must be shortened. The
actions specified by this AD are intended to detect a crack in the web
of the planet gear carrier, which could lead to a MGB seizure and
subsequent loss of control of the helicopter.

DATES: Effective November 12, 2010.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 12, 2010.

ADDRESSES: You may examine the docket that contains this AD, any
comments, and other information on the Internet at http://
www.regulations.gov, or at the Docket Operations office, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington,
DC.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, Texas
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Examining the Docket: You may examine the docket that contains this
AD, any comments, and other information on the Internet at http://
www.regulations.gov, or at the Docket Operations office, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington,
DC.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aerospace Engineer, FAA,
Regulations and Policy Group, 2601 Meacham Blvd., ASW-111, Fort Worth,
Texas 76137; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: A proposal to amend 14 CFR part 39 by
superseding AD 2005-03-09, Amendment 39-13965 (70 FR 7382, February 14,
2005), for the specified Eurocopter France (Eurocopter) model
helicopters was published in the Federal Register on June 28, 2010 (75
FR 36581). The action proposed to require shortening the initial
inspection required by AD 2005-03-09 from 265 hours time-in-service
(TIS) to 35 hours TIS and retaining the 50-hour TIS recurring
inspections. That proposal was prompted by the finding of an additional
crack in the MGB planet gear carrier of a Eurocopter Model EC 155
helicopter. That crack was caused by a progressive fatigue failure
caused by scoring in the blend radius between the pin and the web. An
additional analysis indicates that the initial inspection must be
shortened. Therefore, this AD shortens the initial inspection from 265
hours time-in-service (TIS) to 35 hours TIS. The recurring 50 hour-TIS
inspections would remain the same.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for France, has issued EASA Emergency Airworthiness Directive No.
2007-0288-E, dated November 15, 2007. EASA states that cracks were
discovered in the web of the MGB planet gear carrier. ``The two
affected MGB units had been removed for overhaul/repair, subsequent to
the detection of metal chips at the magnetic plugs.'' Investigation of
the first case showed a failure of the head of a screw that secures the
sun gear bearing. The screw head was caught by the planet gear/fixed
ring gear/sun gear drive train. The second case was discovered by the
manufacturer and did not seem to be associated with any other failure.
You may obtain further information by examining the MCAI and any
related service information in the AD docket.

Related Service Information

    Eurocopter France has issued the following Emergency Alert Service
Bulletins:
     No. 05A007, Revision 2, for the Model EC155 helicopters;
     No. 05.00.48, Revision 3, for the Model AS365 helicopters;

     No. 05.26, Revision 2, for the Model SA360 and SA365
helicopters; and
     No. 05.33, Revision 2, for the SA366 helicopters.

Each Emergency Alert Service Bulletin (EASB) at the stated revision
level is dated November 16, 2009 and describes the discovery of a
progressive fatigue failure of the planet gear carrier. The EASBs
specify inspecting the MGB planet gear carrier for a crack and removing
the MGB and contacting the manufacturer before the next flight if a
crack is found.

FAA's Evaluation and Unsafe Condition Determination

    These products have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, their technical
representative, has notified us of the unsafe condition described in
the MCAI AD. We are proposing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other products of these same type
designs. This AD requires inspecting the MGB planet gear carrier for a
crack and replacing the MGB before further flight if a crack is found.
The actions must be accomplished by following the specified portions of
the EASBs described previously.

Differences Between This Proposed AD and the MCAI AD

    The MCAI AD references the service information rather than stating
compliance times as we have done in this AD. Unlike the MCAI AD, we
have structured our compliance times based on a 250-hour TIS threshold.
Also, this AD does not require you to report cracks in the planet gear
carrier to the manufacturer.

Comments

    Interested persons have been afforded an opportunity to participate
in the making of this amendment. No comments were received on the
proposal or the FAA's determination of the cost to the public. The FAA
has determined that air safety and the public interest require the
adoption of the rule as proposed.

Costs of Compliance

    We estimate that this AD will affect 145 helicopters of U.S.
registry. We also estimate that it will take about 1 work-hour per
helicopter for each borescope inspection and 12 work-hours for each
visual inspection. Replacing the MGB, if necessary, will take about 16
work-hours. The average labor rate is $85 per work-hour. Required parts
will cost about $66,780 per MGB. Based on these figures, we estimate
the cost of this AD on U.S. operators is $3,486,760, assuming that a
borescope inspection is done on the entire fleet 12 times a year, that
no visual inspections are done, and that 49 MGBs are replaced.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. Section 39.13 is amended by removing Amendment 39-13965 (70 FR 7382,
February 14, 2005), and by adding a new airworthiness directive (AD),
Amendment 39-16455, to read as follows:

2010-20-20 Eurocopter France: Amendment 39-16455; Docket No. FAA-
2010-0610; Directorate Identifier 2009-SW-47-AD. Supersedes AD 2005-
03-09; Amendment 39-13965; Docket No. FAA-2005-20294; Directorate
Identifier 2004-SW-39-AD.

    Applicability: Model EC 155B, EC155B1, SA-360C, SA-365C, SA-
365C1, SA-365C2, SA-365N, SA-365N1, AS-365N2, AS 365 N3, and SA-
366G1 helicopters, certificated in any category.
    Compliance: Required as indicated.

------------------------------------------------------------------------
   For a main gearbox (MGB) that has:                Inspect:
------------------------------------------------------------------------
(1) Less than 250 hours time-in-service  On or before the MGB reaches 35
 (TIS) since new or last overhaul.        hours TIS, unless accomplished
                                          previously, and thereafter at
                                          intervals not to exceed 50
                                          hours TIS.
(2) 250 or more hours TIS since new or   Within 15 hours TIS, unless
 last overhaul.                           accomplished previously, and
                                          thereafter at intervals not to
                                          exceed 50 hours TIS.
------------------------------------------------------------------------

    To detect a crack in the web of the planet gear carrier, which
could lead to a MGB seizure and subsequent loss of control of the
helicopter, accomplish the following:
    (a) Either borescope inspect the web of the MGB planet gear
carrier for a crack in accordance with the Operational Procedure,
paragraphs 2.B.2. through 2.B.2.a.1, of Eurocopter Emergency Alert
Service Bulletin (EASB) No. 05A007, Revision 2; No. 05.00.48,
Revision 3; No. 05.26, Revision 2; or No. 05.33, Revision 2; as
applicable to

your model helicopter, or visually inspect the MGB planet gear
carrier in accordance with the Operational Procedure, paragraphs
2.B.3. through paragraph 2.B.3.a.1, of the EASB applicable to your
model helicopter. Each EASB at the stated revision level is dated
November 16, 2009.
    (b) If a crack is found in the planet gear carrier, replace the
MGB with an airworthy MGB before further flight.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Safety Management Group, FAA, Attn: Gary Roach,
Aviation Safety Engineer, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, fax (817)
222-5961, for information about previously approved alternative
methods of compliance.
    (d) The Joint Aircraft System/Component (JASC) Code is 6320:
Main Rotor Gearbox.
    (e) The inspections shall be done in accordance with the
specified portions of Eurocopter Emergency Alert Service Bulletin
No. 05A007, Revision 2, No. 05.00.48, Revision 3, No. 05.26,
Revision 2, or No. 05.33, Revision 2. Each service bulletin at the
stated revision level is dated November 16, 2009. The Director of
the Federal Register approved this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
obtained from American Eurocopter Corporation, 2701 Forum Drive,
Grand Prairie, Texas 75053-4005, telephone<PHONE_NUMBER>, fax (972)
641-3527. Copies may be inspected at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_
register/code_of_federal_regulations/ibr_locations.html.
    (f) This amendment becomes effective on November 12, 2010.

    Note:  The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2007-0288-E, dated November 15, 2007.

    Issued in Fort Worth, Texas, on September 22, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-24725 Filed 10-6-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35872-35874]
[FR Doc No: 2019-15817]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2775]

Food Safety Modernization Act Domestic and Foreign Facility
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal
Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2020 fee rates for certain domestic and foreign
facility reinspections, failures to comply with a recall order, and
importer reinspections that are authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA). These fees are effective on October 1, 2019,
and will remain in effect through September 30, 2020.

FOR FURTHER INFORMATION CONTACT: Tierra Ramsey, Office of Management,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C
Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and
collect fees from, in part: (1) The responsible party for each domestic
facility and the U.S. agent for each foreign facility subject to a
reinspection, to cover reinspection-related costs; (2) the responsible
party for a domestic facility and an importer who does not comply with
a recall order, to cover food \1\ recall activities associated with
such order; and (3) each importer subject to a reinspection to cover
reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees
for each of these activities based on an estimate of 100 percent of the
costs of each activity for each year (sections 743(b)(2)(A)(i), (ii),
and (iv)), and these fees must be made available solely to pay for the
costs of each activity for which the fee was incurred (section
743(b)(3)). These fees are effective on October 1, 2019, and will
remain in effect through September 30, 2020. Section 743(b)(2)(B)(iii)
of the FD&C Act directs FDA to develop a proposed set of guidelines in
consideration of the burden of fee amounts on small businesses. As a
first step in developing these guidelines, FDA invited public comment
on the potential impact of the fees authorized by section 743 of the
FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment
period for this request ended November 30, 2011. As stated in FDA's
September 2011 ``Guidance for Industry: Implementation of the Fee
Provisions of Section 107 of the FDA Food Safety Modernization Act,''
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-implementation-fee-provisions-section-107-fda-food-safety-modernization-act), because FDA recognizes that for
small businesses the full cost recovery of FDA reinspection or recall
oversight could impose severe economic hardship, FDA intends to
consider reducing certain fees for those firms. FDA does not intend to
issue invoices for reinspection or recall order fees until FDA
publishes a guidance document outlining the process through which firms
may request a reduction in fees.
---------------------------------------------------------------------------

    \1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
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    In addition, FDA is in the process of considering various issues
associated with the assessment and collection of importer reinspection
fees. The fee rates set forth in this notice will be used to determine
any importer reinspection fees assessed in FY 2020.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2020

    FDA is required to estimate 100 percent of its costs for each
activity in order to establish fee rates for FY 2020. In each year, the
costs of salary (or personnel compensation) and benefits for FDA
employees account for between 50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the remaining funds (operating
funds) available to FDA are used to support FDA employees for paying
rent, travel, utility, information technology (IT), and other operating
costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2020

    Full-time Equivalent (FTE) reflects the total number of regular
straight-time hours--not including overtime or holiday hours--worked by
employees, divided by the number of compensable hours applicable to
each fiscal year. Annual leave, sick leave, compensatory time off and
other approved leave categories are considered ``hours worked'' for
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of an FTE or paid staff year.
Calculating an Agency-wide total cost per FTE requires three primary
cost elements: Payroll, non-payroll, and rent.
    We have used an average of past year cost elements to predict the
FY 2020 cost. The FY 2020 FDA-wide average cost for payroll (salaries
and benefits) is $160,885; non-payroll--including equipment, supplies,
IT, general and administrative overhead--is $92,828; and rent,
including cost allocation analysis and adjustments for other rent and
rent-related costs, is $24,888 per paid staff year, excluding travel
costs.

    Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2020 average fully supported cost to $278,602 per
FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for reinspection and recall order fees
for FY 2020 prior to including domestic or foreign travel costs as
applicable for the activity.
    To calculate an hourly rate, FDA must divide the FY 2020 average
fully supported cost of $278,602 per FTE by the average number of
supported direct FDA work hours in FY 2018--the last FY for which data
are available. See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2018
------------------------------------------------------------------------

------------------------------------------------------------------------
Total number of hours in a paid staff year...................      2,080
Less:
  10 paid holidays...........................................        -80
  20 days of annual leave....................................       -160
  10 days of sick leave......................................        -80
  12.5 days of training......................................       -100
  26.5 days of general administration........................       -184
  26.5 days of travel........................................       -212
  2 hours of meetings per week...............................       -104
                                                              ----------
Net Supported Direct FDA Work Hours Available for Assignments      1,160
------------------------------------------------------------------------

    Dividing the average fully supported FTE cost in FY 2020 ($278,602)
by the total number of supported direct work hours available for
assignment in FY 2018 (1,160) results in an average fully supported
cost of $240 (rounded to the nearest dollar), excluding inspection
travel costs, per supported direct work hour in FY 2020.

B. Adjusting FY 2018 Travel Costs for Inflation To Estimate FY 2020
Travel Costs

    To adjust the hourly rate for FY 2020, FDA must estimate the cost
of inflation in each year for FY 2019 and FY 2020. FDA uses the method
prescribed for estimating inflationary costs under the Prescription
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1)
(21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment
in the FD&C Act that FDA has used consistently. FDA previously
determined the FY 2019 inflation rate to be 1.7708 percent; this rate
was published in the FY 2019 PDUFA user fee rates notice in the Federal
Register (August 1, 2018, 83 FR 37504). Utilizing the method set forth
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation
rate of 1.7708 percent for 2019 and 2.3964 percent for 2020 and FDA
intends to use these inflation rates to make inflation adjustments for
FY 2020 for several of its user fee programs; the derivation of this
rate will be published in the Federal Register in the FY 2020 notice
for the PDUFA user fee rates.
    The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $240 already takes into account
inflation as the calculation above is based on FY 2020 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
reinspection and recall order fees for FY 2020 prior to including
domestic or foreign travel costs as applicable for the activity. In FY
2018, FDA's Office of Regulatory Affairs (ORA) spent a total of
$6,027,291 for domestic regulatory inspection travel costs and General
Services Administration Vehicle costs related to FDA's Center for Food
Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine
(CVM) field activities programs. The total ORA domestic travel costs
spent is then divided by the 9,976 CFSAN and CVM domestic inspections,
which averages a total of $604 per inspection. These inspections
average 35.44 hours per inspection. Dividing $604 per inspection by
35.44 hours per inspection results in a total and an additional cost of
$17 (rounded to the nearest dollar) per hour spent for domestic
inspection travel costs in FY 2018. To adjust for the $17 per hour
additional domestic cost inflation increases for FY 2019 and FY 2020,
FDA must multiply the FY 2019 PDUFA inflation rate adjustor (1.017708)
times the FY 2020 PDUFA inflation rate adjustor (1.023964) times the
$17 additional domestic cost which results in an estimated cost of $18
(rounded to the nearest dollar) per paid hour in addition to $240 for a
total of $258 per paid hour ($240 plus $18) for each direct hour of
work requiring domestic inspection travel. FDA will use these rates in
charging fees in FY 2020 when domestic travel is required.
    In FY 2018, ORA spent a total of $3,229,335 on 455 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $7,097 per foreign inspection trip.
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing
$7,097 per trip by 120 hours per trip results in a total and an
additional cost of $59 (rounded to the nearest dollar) per paid hour
spent for foreign inspection travel costs in FY 2018. To adjust $59 for
inflationary increases in FY 2019 and FY 2020, FDA must multiply it by
the same inflation factors mentioned previously in this document
(1.017708 and 1.023964), which results in an estimated cost of $61
(rounded to the nearest dollar) per paid hour in addition to $240 for a
total of $301 per paid hour ($240 plus $61) for each direct hour of
work requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2020 when foreign travel is required.

                 Table 2--FSMA Fee Schedule for FY 2019
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2020
------------------------------------------------------------------------
Hourly rate if domestic travel is required..............            $258
Hourly rate if foreign travel is required...............             301
------------------------------------------------------------------------

III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)

A. What will cause this fee to be assessed?

    The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective
actions have been implemented and are effective and compliance has been
achieved to the Secretary of Health and Human Services' (the Secretary)
(and, by delegation, FDA's) satisfaction at a facility that
manufactures, processes, packs, or holds food for consumption
necessitated as a result of a previous inspection (also conducted under
section 704) of this facility, which had a final classification of
Official Action Indicated (OAI) conducted by or on behalf of FDA, when
FDA determined the non-compliance was materially related to food safety
requirements of the FD&C Act. FDA considers such non-compliance to
include non-compliance with a statutory or regulatory requirement under
section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the
FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider non-
compliance that is materially related to a food safety requirement to
include circumstances where the non-compliance is of a technical nature
and not food safety related (e.g., failure to comply with a food
standard or incorrect font size on a food label). Determining when non-
compliance, other than under sections 402 and 403(w) of the FD&C Act,
is materially related to a food safety requirement of the FD&C Act may
depend on the facts of a particular situation. FDA intends to issue
guidance

to provide additional information about the circumstances under which
FDA would consider non-compliance to be materially related to a food
safety requirement of the FD&C Act.
    Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to
assess and collect fees from ``the responsible party for each domestic
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the
United States agent for each foreign facility subject to a
reinspection'' to cover reinspection-related costs.
    Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified non-compliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
    The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section 743(a)(1)(A) of the FD&C Act to collect fees from
the U.S. agent of a foreign facility subject to a reinspection, the
Agency is using the following definition of ``reinspection'' for
purposes of assessing and collecting fees under section 743(a)(1)(A),
with respect to a foreign facility, ``1 or more inspections conducted
by officers or employees duly designated by the Secretary subsequent to
such an inspection which identified non-compliance materially related
to a food safety requirement of the FD&C Act, specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction.''
    This definition allows FDA to fulfill the mandate to assess and
collect fees from the U.S. agent of a foreign facility in the event
that an inspection reveals non-compliance materially related to a food
safety requirement of the FD&C Act, causing one or more subsequent
inspections to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the
initial inspection to be conducted by officers or employees duly
designated by the Secretary, the definition ensures that a foreign
facility would be subject to fees only in the event that FDA, or an
entity designated to act on its behalf, has made the requisite
identification at an initial inspection of non-compliance materially
related to a food safety requirement of the FD&C Act. The definition of
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act
relates to both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)(1)(A).

B. Who will be responsible for paying this fee?

    The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the U.S. agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send
the invoice for any fees that are assessed under this section.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 2 of this
document.

IV. Fees for Non-Compliance With a Recall Order Under Section
743(a)(1)(B)

A. What will cause this fee to be assessed?

    The fee will be assessed for not complying with a recall order
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with
such order performed by the Secretary (and by delegation, FDA) (section
743(a)(1)(B) of the FD&C Act). Non-compliance may include the
following: (1) Not initiating a recall as ordered by FDA; (2) not
conducting the recall in the manner specified by FDA in the recall
order; or (3) not providing FDA with requested information regarding
the recall, as ordered by FDA.

B. Who will be responsible for paying this fee?

    Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act) and an importer who does not comply
with a recall order under section 423 or under section 412(f) of the
FD&C Act. In other words, the party paying the fee would be the party
that received the recall order.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and
from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 2 of this document.

V. How Must the Fees Be Paid?

    An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 90 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.

VI. What Are the Consequences of Not Paying These Fees?

    Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the U.S.
Government subject to provisions of subchapter II of chapter 37 of
title 31, United States Code.

    Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15817 Filed 7-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Proposed Rules]
[Pages 30851-30854]
[FR Doc No: 2021-12168]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2021-0214]
RIN 1625-AA08

Special Local Regulation; Breton Bay, McIntosh Run, Leonardtown,
MD

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish special local
regulations for certain waters of Breton Bay and McIntosh Run. This
action is necessary to provide for the safety of life on these
navigable waters located at Leonardtown, MD, during a high-speed power
boat demonstration event on July 31, 2021, and August 1, 2021. This
proposed rulemaking would prohibit persons and vessels from being in
the regulated area unless authorized by the Captain of the Port
Maryland-National Capital Region or the Event Patrol Commander. We
invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 25, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0214 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST1 Shaun Landante, U.S. Coast
Guard Sector Maryland-National Capital Region; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Southern Maryland Boat Club of Leonardtown, MD, has notified
the Coast Guard that it will be conducting the Southern Maryland Boat
Club Wharf Summer Regatta from 9:30 a.m. to 4 p.m. on July 31, 2021,
and from 10:15 a.m. to 4 p.m. on August 1, 2021. The high-speed boat
event consists of approximately 50 participating vintage and historic
race boats--including runabouts, v-bottoms, tunnel hulls, and
hydroplanes--12 to 21 feet in length. The boats will be participating
in an exhibition, operating in heats along a marked racetrack-type
course 1 mile in length and 150 feet in width, located in Breton Bay
and McIntosh Run at Leonardtown, MD. The Regatta is not a competition,
but rather a demonstration of the vintage race craft. Hazards from the
high-speed power boat demonstration event include participants
operating within and adjacent to designated navigation channels and
interfering with vessels intending to operate within those channels, as
well as operating within approaches to local public boat landings. The
Captain of the Port (COTP) Maryland-National Capital Region has
determined that potential hazards associated with the high-speed power
boat event would be a safety concern for anyone intending to operate
within certain waters of Breton Bay and McIntosh Run at Leonardtown,
MD, operating in or near the event area.
    The purpose of this rulemaking is to protect event participants,
non-participants, and transiting vessels before, during, and after the
scheduled event. The Coast Guard proposes this rulemaking under
authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).
    The Coast Guard is requesting that interested parties provide
comments within a shortened comment period of 15 days instead of the
more typical 30 days for this notice of proposed rulemaking. The Coast
Guard believes the 15-day comment period still provides for a
reasonable amount of time for interested parties to review the

proposal and provide informed comments on it while also ensuring that
the Coast Guard has time to review and respond to any significant
comments and has final rule in effect in time for the scheduled event.

III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region proposes to establish
special local regulations from 7 a.m. on July 31, 2021, through 6 p.m.
on August 1, 2021. The special local regulation would be enforced from
7 a.m. through 6 p.m. on July 31st and 7 a.m. through 6 p.m. on August
1st. The regulated area would cover all navigable waters of Breton Bay
and McIntosh Run, immediately adjacent to Leonardtown, MD, within an
area bounded by lines drawn shoreline to shoreline, to the south along
latitude 38[deg]16'43'' N and to the west along longitude
076[deg]38'30'' W.
    This proposed rule provides additional information about areas
within the regulated area, and the restrictions that would apply to
mariners. These areas include a ``Race area'', ``Buffer area'',
``Milling area'' and ``Spectator area''. They lie within an area
bounded to the south by a line drawn along latitude 38[deg]16'43'' N
and bounded to the west by a line drawn along longitude 076[deg]38'30''
W, located in Breton Bay and McIntosh Run, at Leonardtown, MD.
    The proposed duration of the special local regulations and size of
the regulated area are intended to ensure the safety of life on these
navigable waters before, during, and after the high-speed power boat
event, scheduled from 9:30 a.m. until 4 p.m. on July 31, 2021, and from
10:15 a.m. until 4 p.m. on August 1, 2021. The COTP and the Coast Guard
Event Patrol Commander (PATCOM) would have authority to forbid and
control the movement of all vessels and persons, including event
participants, in the regulated area. When hailed or signaled by an
official patrol, a vessel or person in the regulated area would be
required to immediately comply with the directions given by the COTP or
Event PATCOM. If a person or vessel fails to follow such directions,
the Coast Guard may expel them from the area, issue them a citation for
failure to comply, or both.
    Except for Southern Maryland Boat Club Regatta participants and
vessels already at berth, a vessel or person would be required to get
permission from the COTP or Event PATCOM before entering the regulated
area. Vessel operators can request permission to enter and transit
through the regulated area by contacting the Event PATCOM on VHF-FM
channel 16. Vessel traffic would be able to safely transit the
regulated area once the Event PATCOM deems it safe to do so. A person
or vessel not registered with the event sponsor as a participant or
assigned as official patrols would be considered a spectator. Official
Patrols are any vessel assigned or approved by the Commander, Coast
Guard Sector Maryland-National Capital Region with a commissioned,
warrant, or petty officer on board and displaying a Coast Guard ensign.
    If permission is granted by the COTP or Event PATCOM, a person or
vessel would be allowed to enter the regulated area or pass directly
through the regulated area as instructed. Vessels would be required to
operate at a safe speed that minimizes wake while within the regulated
area. Official patrol vessels would direct everyone other than
participants while within the regulated area. Spectators are only
allowed inside the regulated area if they remain within a designated
spectator area. Only participants and official patrols are allowed
within the race area and milling area.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on size, duration and
time of year of the regulated area, which would impact a small
designated area of Breton Bay and McIntosh Run for 22 total enforcement
hours. This waterway supports mainly recreational vessel traffic, which
at its peak, occurs during the summer season. Although this regulated
area extends across the entire width of the waterway, the rule would
allow vessels and persons to seek permission to enter the regulated
area, and vessel traffic able to do so safely would be able to transit
the regulated are as instructed by Event PATCOM. Such vessels must
operate at safe speed that minimizes wake and not loiter within the
navigable channel while within the regulated area. Moreover, the Coast
Guard would issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the status of the regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132

(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area lasting for eight hours. Normally
such actions are categorically excluded from further review under
paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. For instructions on locating the docket, see the
ADDRESSES section of this preamble. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. 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 https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. We review all comments received, but we will only post
comments that address the topic of the proposed rule. We may choose not
to post off-topic, inappropriate, or duplicate comments that we
receive. 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.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0214 to read as follows:

Sec.  100.T05-0214   Southern Maryland Boat Club Leonardtown Regatta,
Breton Bay, McIntosh Run, Leonardtown, MD.

    (a) Locations. All coordinates reference Datum NAD 1983.
    (1) Regulated area. All navigable waters of Breton Bay and McIntosh
Run, immediately adjacent to Leonardtown, MD shoreline, from shoreline
to shoreline, within an area bounded to the east by a line drawn along
latitude 38[deg]16'43'' N and bounded to the west by a line drawn along
longitude 076[deg]38'30'' W, located at Leonardtown, MD. The locations
in paragraphs (a)(2) through (5) of this section are within the
regulated area.
    (2) Race area. The area is bounded by a line commencing at position
latitude 38[deg]17'09.78'' N, longitude 076[deg]38'22.71'' W; thence
southeasterly to latitude 38[deg]16'58.62'' N, longitude
076[deg]37'50.91'' W; thence southwesterly to latitude
38[deg]16'51.89'' N, longitude 076[deg]37'55.82'' W; thence
northwesterly to latitude 38[deg]17'05.44'' N, longitude
076[deg]38'27.20'' W; thence northeasterly terminating at point of
origin.
    (3) Buffer area. The area surrounds the entire race area described
in paragraph (a)(2) of this section. The area is bounded by a line
commencing at the shoreline west of Leonardtown Wharf Park at position
latitude 38[deg]17'13.80'' N, longitude 076[deg]38'24.72'' W; thence
easterly to latitude 38[deg]16'58.61'' N, longitude 076[deg]37'44.29''
W; thence southerly to latitude 38[deg]16'46.35'' N, longitude
076[deg]37'52.54'' W; thence westerly to latitude 38[deg]16'58.78'' N,
longitude 076[deg]38'26.63'' W; thence northerly to latitude
38[deg]17'07.50'' N, longitude 076[deg]38'30.00'' W; thence
northeasterly terminating at point of origin.
    (4) Milling area. The area is bounded by a line commencing at the
shoreline east of Leonardtown Wharf Parkat position latitude
38[deg]17'10.07'' N, longitude 076[deg]38'14.87'' W; thence

easterly and southerly along the shoreline to latitude
38[deg]17'01.54'' N, longitude 076[deg]37'52.24'' W; thence westerly
terminating at point of origin.
    (5) Spectator area--(i) Northeast spectator fleet area. The area is
bounded by a line commencing at position latitude 38[deg]16'59.10'' N,
longitude 076[deg]37'45.60'' W, thence northeasterly to latitude
38[deg]17'01.76'' N, longitude 076[deg]37'43.71'' W, thence
southeasterly to latitude 38[deg]16'59.23'' N, longitude
076[deg]37'37.25'' W, thence southwesterly to latitude
38[deg]16'53.32'' N, longitude 076[deg]37'40.85'' W, thence
northwesterly to latitude 38[deg]16'55.48'' N, longitude
076[deg]37'46.39'' W, thence northeasterly to latitude
38[deg]16'58.61'' N, longitude 076[deg]37'44.29'' W, thence
northwesterly to point of origin.
    (ii) Southeast spectator fleet area. The area is bounded by a line
commencing at position latitude 38[deg]16'47.20'' N, longitude
076[deg]37'54.80'' W, thence southerly to latitude 38[deg]16'43.30'' N,
longitude 076[deg]37'55.20'' W, thence easterly to latitude
38[deg]16'43.20'' N, longitude 076[deg]37'47.80'' W, thence northerly
to latitude 38[deg]16'44.80'' N, longitude 076[deg]37'48.20'' W, thence
northwesterly to point of origin.
    (iii) South spectator fleet area. The area is bounded by a line
commencing at position latitude 38[deg]16'55.36'' N, longitude
076[deg]38'17.26'' W, thence southeasterly to latitude
38[deg]16'50.39'' N, longitude 076[deg]38'03.69'' W, thence southerly
to latitude 38[deg]16'48.87'' N, longitude 076[deg]38'03.68'' W, thence
northwesterly to latitude 38[deg]16'53.82'' N, longitude
076[deg]38'17.28'' W, thence northerly to point of origin.
    (b) Definitions. As used in this section:
    Buffer area is a neutral area that surrounds the perimeter of the
race area within the regulated area described by this section. The
purpose of a buffer area is to minimize potential collision conflicts
with marine event participants or race boats and spectator vessels or
nearby transiting vessels. This area provides separation between a race
area and specified spectator areas or other vessels that are operating
in the vicinity of the regulated area established by the special local
regulations in this section.
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Event Patrol Commander or Event PATCOM means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Milling area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a
milling area within the regulated area defined by this section. The
area is used before a demonstration start to warm up the boats engines.
    Official patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means a person or vessel registered with the event
sponsor as participating in the Southern Maryland Boat Club Leonardtown
Regatta or otherwise designated by the event sponsor as having a
function tied to the event.
    Race area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a
high-speed power boat demonstration area within the regulated area
defined by this section.
    Spectator means a person or vessel not registered with the event
sponsor as participants or assigned as official patrols and is present
with the purpose of observing the event.
    Spectator area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a
spectator area within the regulated area defined by this section.
    (c) Special local regulations. (1) The COTP Maryland-National
Capital Region or Event PATCOM may forbid and control the movement of
all vessels and persons, including event participants, in the regulated
area. When hailed or signaled by an official patrol, a vessel or person
in the regulated area shall immediately comply with the directions
given by the patrol. Failure to do so may result in the Coast Guard
expelling the person or vessel from the area, issuing a citation for
failure to comply, or both. The COTP Maryland-National Capital Region
or Event PATCOM may terminate the event, or a participant's operations
at any time the COTP Maryland-National Capital Region or Event PATCOM
believes it necessary to do so for the protection of life or property.
    (2) Except for participants and vessels already at berth, a person
or vessel within the regulated area at the start of enforcement of this
section must immediately depart the regulated area.
    (3) A spectator must contact the Event PATCOM to request permission
to either enter or pass through the regulated area. The Event PATCOM,
and official patrol vessels enforcing this regulated area, can be
contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and
channel 22A (157.1 MHz). If permission is granted, the spectator must
pass directly through the regulated area as instructed by Event PATCOM.
A vessel within the regulated area must operate at safe speed that
minimizes wake.
    (4) Only participant vessels and official patrol vessels are
allowed to enter the race area and milling area.
    (5) Only participant vessels and official patrol vessels are
allowed to enter and transit directly through the buffer area, in order
to arrive at or depart from the race area.
    (6) A person or vessel that desires to transit, moor, or anchor
within the regulated area must obtain authorization from the COTP
Maryland-National Capital Region or PATCOM. A person or vessel seeking
such permission can contact the COTP Maryland-National Capital Region
at telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz) or the PATCOM on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz).
    (7) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event date
and times.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 7 a.m.
to 6 p.m. on July 31, 2021, and from 7 a.m. to 6 p.m. on August 1,
2021.

    Dated: June 4, 2021.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2021-12168 Filed 6-9-21; 8:45 am]
BILLING CODE 9110-04-P