[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Rules and Regulations]
[Page 22672-22685]
[DOCID:fr14my09-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2008-0386]
RIN 1625-AA08

Marine Events Regattas; Annual Marine Events in the Eighth Coast
Guard District

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is updating the list of marine events and
regattas that take place in the Eighth Coast Guard District and
changing patrol requirements for these events. This update informs the
public of regularly scheduled regattas and marine events and
facilitates effective control over regattas and marine events to insure
safety of life in each regatta or marine event area.

DATES: This final rule is effective June 15, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0386 and are 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. You may also find this
docket on the Internet by going to http://www.regulations.gov,
selecting the Advanced Docket Search option on the right side of the
screen, inserting USCG-2008-0386 in the Docket ID box, pressing Enter,
and then clicking on the item in the Docket ID column.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Dr. Madeleine McNamara, Eighth Coast Guard District
Prevention Division, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Regulatory History
III. Background
IV. Discussion of Comments and Changes
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

DHS--Department of Homeland Security.
FR--Federal Register.
Sec. --Section symbol.
U.S.C.--United States Code.

II. Regulatory History

    On June 16, 2008, we published a notice of proposed rulemaking
entitled ``Marine Events Regattas; Annual Marine Events in the Eighth
Coast Guard District'' in the Federal Register (73 FR 116). We received
no comments on the proposed rule. No public meeting was requested and
none was held.

III. Background

    33 CFR part 100 provides regulations to provide effective control
over regattas and marine parades conducted on U.S. navigable waters to
insure safety of life in the regattas or marine parade area. Section
100.801 list recurring events that take place in the Eighth Coast Guard
District. This section needed to be updated because the Coast Guard
reorganized Coast Guard Group Offices and Marine Safety Offices into
Coast Guard Sectors and because the list of events in Table 1 of
Sec.100.801 was out of date needed to be revised to reflect current
events.
    This regulation also modifies Coast Guard patrol requirements for
Eighth Coast Guard District regattas and marine parades. Section
100.801(a) requires the Coast Guard to patrol marine events in the
Eighth Coast Guard District. The Coast Guard feels that not all events
require Coast Guard patrols and therefore leaves the decision of
whether to patrol these events to the discretion of the local Coast
Guard Captain of the Port.

IV. Discussion of Comments and Changes

    No comments were received regarding the published NPRM. Therefore,
the final rule text is largely the same as the text published in the
NPRM.
    The following general changes were made to the regulatory text.
Paragraph (i) was added to clarify the definition of each regulated
area. Paragraph (j) was added to advise mariners of where to look for
more specific information about recurring marine events. Events were

renumbered for ease of reference. References to ``mile markers'' were
changed to ``miles'' in recognition that not every tenth of a mile on a
waterway has a signpost. Several locations were clarified by adding the
name of a city or river, additional mile references, or points of
latitude and longitude. Where the title of an event makes reference to
the year or the number of recurances (i.e. ``Riverfest 2007'' or
``Rodeofest XXVI''), the year or number was removed.
    The following specific changes were made to individual regulated
areas. Within each Sector's list of events, each event is referred to
by the event number in the NPRM, then the new number assigned in the
final rule, then the title of the event.
I. Sector Ohio Valley
7./7. Indiana Governor's Cup
    ``Four days'' was clarified to ``Thursday through Sunday.''
27./[n/a] Dragon Boat Festival
    The Dragon Boat Festival in Pittsburgh, PA, was removed from the
list entirely.
II. Sector Upper Mississippi River
1./29. Hudson Hot Air Affair.
    Clarified the regulated area by adding upper and lower bounds.
3./31. St. Patrick's Water Parade.
    This event is deleted from the Final Rule. The regulated area
``Lake of the Ozarks mile 013.0'' was not the intended area. The space
in the table is reserved to facilitate re-adding this event in a future
rulemaking.
4./32. Deke Slayton Airfest, LaCrosse
    Clarified the regulated area by adding upper and lower bounds.
7./35. Lodge of the Four Seasons Memorial Day
    Clarified the regulated area by adding upper and lower bounds.
9./37. Burlington Steamboat Days
    Clarified the regulated area by adding upper and lower bounds.
11./39. Taste of the Quad Cities
    Clarified the regulated area by adding upper and lower bounds.
12./40. Great Rivers Towboat Festival
    Clarified the regulated area by adding upper and lower bounds.
14./42. Taste of Minnesota
    Clarified the regulated area by adding upper and lower bounds.
15./43. Sioux City Big Parade
    Clarified the regulated area by adding upper and lower bounds.
16./44. KC Riverfest/Kansas City Riverfest
    Clarified the regulated area by adding upper and lower bounds.
Clarified event name and sponsor.
19./47. 3rd Annual Dosh River Rally/Annual Dosh River Rally
    Clarified the regulated area by adding upper and lower bounds.
Removed ``3rd'' from event name.
23./51. Riverfest 2007/Riverfest
    Removed ``2007'' from event name.
24./52. Red White and Boom
    Clarified the regulated area by adding upper and lower bounds.
27./55. John E. Curran Fireworks
    Clarified the regulated area by adding upper and lower bounds.
29./57. Red White and Boom Peoria
    Reordered upper and lower bounds.
31./59. Minneiska 4th of July
    Clarified the regulated area by adding upper and lower bounds.
34./62. Hermann 4th of July
    Clarified the regulated area by adding upper and lower bounds.
37./65. Mike Herrington Fireworks
    Clarified the regulated area by adding upper and lower bounds.
38./66. Riverfest, La Crosse
    Clarified the regulated area by adding upper and lower bounds.
40./68. Grafton Chamber 4th of July Fireworks
    Clarified the regulated area by adding upper and lower bounds.
41./69. Parkville 4th of July Fireworks
    Clarified the regulated area by adding upper and lower bounds.
42./70. Harrah's Fireworks Extravaganza
    Clarified the regulated area by adding upper and lower bounds.
43./71. Hooligan Bay Fireworks Display
    Clarified the regulated area by adding upper and lower bounds.
44./72. Tan-Tar-A 4th of July Fireworks
    Clarified the regulated area by adding upper and lower bounds.
45./73. Red White and Boom Minneapolis
    Clarified the regulated area by adding upper and lower bounds.
47./75. Lodge of the Four Seasons 4th of July
    Clarified the regulated area by adding upper and lower bounds.
48./76. Gravois Mills Fireworks
    Clarified the regulated area by adding upper and lower bounds.
50./78. Prairie du Chien Area Chamber Fireworks
    Clarified the regulated area by adding upper and lower bounds.
52./80. Stars and Stripes River Day
    Clarified the regulated area by adding upper and lower bounds.
53./81.
    Clarified the regulated area by adding upper and lower bounds.
54./82. Lumberjack Days
    Clarified the regulated area by adding upper and lower bounds.
55./83. Prairie Air Show
    Clarified the regulated area by adding upper and lower bounds.
59./87. Cassville Twin-O-Rama
    Clarified the regulated area by adding upper and lower bounds.
61./89. River City Days
    Clarified the regulated area by adding upper and lower bounds.
62./90. New Piasa Chataqua
    Clarified the regulated area by adding upper and lower bounds.
67./95. Tan-Tar-A-Fireworks
    Clarified the regulated area by adding upper and lower bounds.
68./96. Mike Herrington Labor Day Fireworks
    Clarified the regulated area by adding upper and lower bounds.
69./97. Lodge of the Four Seasons
    Clarified the regulated area by adding upper and lower bounds.
74./102. Railroad Days
    Clarified the regulated area by adding upper and lower bounds.
Sector Houston-Galveston
1./117. Port Arthur Fourth of July Fireworks Demonstration.
    Replaced references to ``Wilson Middle School'' and ``Old Golf
Course Road'' with miles on the waterway.

Sector New Orleans
4./131. Lundi Gras River Parade and Fireworks Display
    Clarified regulated area by removing extraneous details.
Sector Mobile Events
1./141. Seroma's 4th of July
    Defined regulated area using latitude and longitude instead of
local landmarks and defined the regulated area as a radius instead of a
point.
2./142. South Georgia Showdown
    Defined regulated area using miles on the Flint River instead of
landmarks.
3./143. Thunder on the Gulf
    Defined regulated area as a four sided box using latitude and
longitude points instead of landmarks.
4./144. GYA Challenge Cup
    This event was removed from the list but the line is reserved to
facilitate re-adding the event in the future.
8./148. Isle of Capri Anniversary Celebration
    Defined regulated area using latitude and longitude instead of
local landmarks.
15./155. Christmas Afloat
    Clarified the regulated area.
20./160. Blue Angels Air Show
    Defined the regulated area to exclude the interior waters of
Pensacola Bay.
22./162. Mardi Gras Boat Parade
    Clarified the regulated area.
23./163. Blessing of the Fleet
    Clarified the regulated area.

V. 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.

A. 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.
    The Coast Guard expects the economic impact of this rule to be so
minimal that a full regulatory evaluation is unnecessary.
    The regattas and marine parades listed in this rule will restrict
vessel traffic from transiting certain areas of Eighth Coast Guard
District waters; however the effect of this regulation will not be
significant because these events are short duration and the special
local regulation governing vessel movements and restrictions are also
short duration. Additionally, the public is given advance notification
through the Federal Register and thus will be able to plan operations
around the event in advance.

B. 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.
    This proposed rule may affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to transit the regulated area during the regattas or marine parade. The
special local regulations will not have a significant economic impact
on a substantial number of small entities for the following reasons.
This rule will be in effect for short periods of times and vessel
traffic can pass safely around the regulated area or through the
regulated area with permission of the patrol commander. And before the
effective period, the Coast Guard Captain of the Port will issue
maritime advisories widely available to users of the river. Therefore,
the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule
will not have a significant economic impact on a substantial number of
small entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking. Small entities
were given a point-of-contact to direct questions regarding the
provisions of this rule and options for compliance. 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.

D. 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).

E. 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.

F. 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.

G. 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.

H. 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.

I. 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.

J. 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.

K. 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.

L. 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.

M. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023.1 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
that 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 section 2.B.2,
figure 2-1, paragraph (34)(h) of the Instruction.

List of Subjects in 33 CFR Part 100

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

0
For the reasons discussed in the preamble, the Coast Guard amends 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: 33 U.S.C. 1233.

0
2. Amend Sec.  100.801 to revise paragraph (a), add paragraphs (i) and
(j), and revise table 1 to read as follows:

Sec.  100.801  Annual Marine Events in the Eighth Coast Guard District.

* * * * *
    (a) The Coast Guard may patrol the event area under the direction
of a designated Coast Guard Patrol Commander. The Patrol Commander may
be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign
``PATCOM.''
* * * * *
    (i) In Table 1 to this section, where a regulated area is described
by reference to miles of a river, channel or lake, the regulated area
includes all waters between the indicated miles as defined by lines
drawn perpendicular to shore passing through the indicated points.
    (j) In Table 1 to this section, where alternative dates are
described (``third or fourth Saturday''), the exact date and times will
be advertised by the Coast Guard through Local Notices to Mariners and
Broadcast Notices to Mariners.

 Table 1 of Sec.   100.801--Eighth Coast Guard District Table of Annual
                              Marine Events
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                          I. SECTOR OHIO VALLEY

1. WEBN/Riverfest Fireworks
    Sponsor: WEBN.
    Date: The Sunday before Labor Day.
    Regulated Area: Ohio River miles 469.2-470.5, Cincinnati, OH.
2. Aurora Thunder Regatta
    Sponsor: Aurora Riverfront Beautification Committee.
    Date: The last weekend in August.
    Regulated Area: Ohio River channel miles 496.0-499.0, Aurora, IN.
3. Ohio River Way Paddlefest
    Sponsor: Ohio River Way (Paddlefest).
    Date: The last weekend in June.
    Regulated Area: Ohio River miles 461.5-470.5, Cincinnati, OH.
4. Thunder Over Louisville.
    Sponsor: Thunder Over Louisville.
    Date: Five days during the 2nd half of April.
    Regulated Area: Ohio River miles 602.0-606.0, Louisville, KY.
5. Kentucky Derby Festival Great Steamboat Race
    Sponsor: Kentucky Derby Festival/Belle of Louisville Operating
     Board.
    Date: One day during the last week in April or the first week in
     May.
    Regulated Area: Ohio River miles 596.0-604.3, Louisville, KY.
6. Thunder on the Ohio
    Sponsor: Evansville Freedom Festival.
    Date: Six days during the last week in June and/or the first week in
     July.
    Regulated Area: Ohio River miles 791.0-795.0, Evansville, IN.
7. Indiana Governor's Cup
    Sponsor: Madison Regatta Inc.
    Date: Thursday through Sunday over the 1st weekend in July.
    Regulated Area: Ohio River miles 555.0-560.0, Madison, IN.
8. Kentucky Drag Boat Association Inc.: Drag Boat Races
    Sponsor: Kentucky Drag Boat Association Inc.
    Date: Three days between August 15th and August 31st.
    Regulated Area: Green River miles 70.0-71.5, Livermore, KY.

9. Ducks on the Ohio
    Sponsor: Goodwill Industries, Inc.
    Date: One day between August 15th and September 30th.
    Regulated Area: Ohio River miles 791.5-793.5, Evansville, IN.
10. Clarksville Riverfest--Wakeboard Contest, Regatta, Fireworks
    Sponsor: City of Clarksville, TN.
    Date: The 2nd weekend in September.
    Regulated Area: Cumberland River miles 125-126.
11. Spirit of Freedom Fireworks Florence, TN--Fireworks
    Sponsor: Urban Broadcasting.
    Date: July 4th.
    Regulated Area: Tennessee River miles 255-257.
12. Lake Guntersville 4th of July Celebration--Fireworks
    Sponsor: Lake Guntersville, AL Chamber of Commerce.
    Date: July 4th.
    Regulated Area: Tennessee River miles 356-358.
13. The Great Kiwanis Duck Race--Rubber Duck Regatta
    Sponsor: Kiwanis Club of Chattanooga, TN.
    Date: The 3rd weekend in June.
    Regulated Area: Tennessee River miles 463-464.
14. Chattanooga Dragon Boat Festival--Rowing Race
    Sponsor: Dynamic Events and Management.
    Date: The 1st weekend in August.
    Regulated Area: Tennessee River miles 463-464.
15. Pickwick Challenge--Powerboat Race
    Sponsor: Pickwick Challenge, LLC.
    Date: The 1st weekend in May.
    Regulated Area: Tennessee River miles 206-210.
16. Lighting Up the Cumberland--Fireworks
    Sponsor: Town of Cumberland City, TN.
    Date: The Saturday before July 4th, or on July 4th if that day is a
     Saturday.
    Regulated Area: Cumberland River miles 103-105.
17. Knoxville Dragon Boat Races--Rowing Race
    Sponsor: Dynamic Events & Management.
    Date: The 4th Weekend in August.
    Regulated Area: Tennessee River miles 647-648.
18. Marietta Invitational Rowing Regatta
    Sponsor: Marietta High School.
    Date: One day during the 2nd or 3rd weekend in April.
    Regulated Area: Muskingum River miles 0.5-1.5, Marietta, OH.
19. West Virginia Governor's Cup Regatta
    Sponsor: University of Charleston.
    Date: One day during the 2nd or 3rd weekend in April.
    Regulated Area: Kanawha River miles 59.5-62.0, Charleston, WV.
20. Point Pleasant Sternwheel Regatta
    Sponsor: City of Point Pleasant.
    Date: Three days during the 1st or 2nd weekend in July.
    Regulated Area: Ohio River miles 265.0-266.0, Point Pleasant, WV.
21. Charleston 4th of July Celebration
    Sponsor: City of Charleston.
    Date: Two days during the 1st week in July.
    Regulated Area: Kanawha River miles 57.5-59.0, Charleston, WV.
22. Summer Motion
    Sponsor: Summer Motion Inc.
    Date: Three days during the 1st week in July.
    Regulated Area: Ohio River miles 321.6-323.3.
23. Marietta Riverfront Roar Tunnel Boat Races
    Sponsor: Marietta Riverfront Roar.
    Date: Two days during either the 2nd or 3rd weekend in July.
    Regulated Area: Ohio River miles 171.5-172.5, Marietta, OH.
24. Dawg Dazzle Fireworks Spectacular
    Sponsor: Big Sandy Superstore Arena.
    Date: One day during the 1st week in July.
    Regulated Area: Ohio River miles 307.8-308.8, Huntington, WV.
25. Brundage Memorial Regatta
    Sponsor: Brundage Regatta Committee.
    Date: One day during the 3rd or 4th weekend in May.
    Regulated Area: Ohio River miles 182.5-183.5.
26. St. Mary Medical Center Foundation Gala
    Sponsor: St. Mary Medical Center Foundation.
    Date: One day during the 2nd or 3rd weekend in May.
    Regulated Area: Ohio River miles 307.8-308.8.
27. Pirates Fireworks
    Sponsor: Pittsburgh Pirates.

    Date: Every Saturday from April through September.
    Regulated Area: Allegheny River miles 0.4-0.6, Pittsburgh, PA.
28. Wheeling Vintage Regatta
    Sponsor: Wheeling Vintage Race Boat Association.
    Date: Labor Day weekend.
    Regulated Area: Ohio River miles 90.4-91.5, Wheeling, WV.

                   II. SECTOR UPPER MISSISSIPPI RIVER

29. Hudson Hot Air Affair
    Sponsor: Hudson Hot Air Affair, Inc.
    Dates: The 1st Friday in February.
    Regulated Area: St. Croix River miles 16.5-16.9.
30. Winter Carnival--Comcast Fireworks
    Sponsor: St. Paul Festival and Heritage Foundation.
    Dates: The 1st Saturday in February.
    Regulated Area: Upper Mississippi River miles 840.5-841.0.
31. [RESERVED].
32. Deke Slayton Airfest, LaCrosse
    Sponsor: Deke Slayton Airfest.
    Dates: Three days during the 3rd week in May.
    Regulated Area: Upper Mississippi River miles 702.5-703.5.
33. That Was Then, This Is Now Boat Show & Exhibition
    Sponsor: Clear Lake Chapter of the ACBS.
    Dates: The 3rd Saturday in May.
    Regulated Area: Upper Mississippi River miles 454.0-456.0.
34. Tan-Tar-A Memorial Day Fireworks
    Sponsor: Tan-Tar-A Resort.
    Dates: The last Sunday in May.
    Regulated Area: Lake of the Ozarks miles 025.5-26.5.
35. Lodge of the Four Seasons Memorial Day
    Sponsor: Lodge of the Four Seasons.
    Dates: The last Sunday in May.
    Regulated Area: Lake of the Ozarks miles 013.5-14.5.
36. Steamboat Sports Festival
    Sponsor: Peoria Area Community Events.
    Dates: Two days during the 2nd weekend in June.
    Regulated Area: Illinois River miles 162.3-163.7.
37. Burlington Steamboat Days
    Sponsor: Burlington Steamboat Days.
    Dates: The 3rd Sunday in June.
    Regulated Area: Upper Mississippi River miles 403.5-404.5.
38. Winona Steamboat Days Fireworks
    Sponsor: Winona Steamboat Days Festival.
    Dates: The 3rd Sunday in June.
    Regulated Area: Upper Mississippi River miles 725.4-725.7.
39. Taste of the Quad Cities
    Sponsor: Taste of the Quad Cities.
    Dates: The 2nd Friday in June.
    Regulated Area: Upper Mississippi River mile 485.0-485.5.
40. Great Rivers Towboat Festival
    Sponsor: Great Rivers Towboat Festival.
    Dates: Two days during the 3rd Weekend in June.
    Regulated Area: Illinois River miles 0.2-0.5
41. Water Ski Days
    Sponsor: Lake City Chamber of Commerce.
    Dates: Two days during the 3rd Weekend in June.
    Regulated Area: Upper Mississippi River miles 772.4-772.8.
42. Taste of Minnesota
    Sponsor: Taste of Minnesota.
    Dates: Five days during the last week in June and/or the first week
     in July.
    Regulated Area: Upper Mississippi River mile 839.5-840.5.
43. Sioux City Big Parade
    Sponsor: City of Sioux City.
    Dates: One day during the last weekend in June.
    Regulated Area: Missouri River miles 731.0-733.0
44. Kansas City Riverfest
    Sponsor: Friends of the River (FOR-KC), Inc.
    Dates: One day during the last weekend in June or the first weekend
     in July.
    Regulated Area: Missouri River miles 365.5-370.5.
45. Bellevue Heritage Days
    Sponsor: Bellevue Heritage Days.
    Dates: One day during the last weekend in June or the first weekend
     in July.
    Regulated Area: Upper Mississippi River miles 556.6-557.0.
46. Hudson Booster Days
    Sponsor: Hudson Boosters.

    Dates: One day during the last weekend in June or the first weekend
     in July.
    Regulated Area: St. Croix River miles 017.0-017.2.
47. Annual Dosh River Rally
    Sponsor: Village of Meredosia.
    Dates: One day during the 1st weekend in July.
    Regulated Area: Illinois River miles 072.0-072.2.
48. Mississippi Fireworks Festival
    Sponsor: Alton Exposition Commission.
    Dates: Either the 3rd or 4th day of July.
    Regulated Area: Upper Mississippi River miles 202.5-203.0.
49. Radio Dubuque
    Sponsor: Radio Dubuque.
    Dates: Either the 3rd or 4th day of July.
    Regulated Area: Upper Mississippi River miles 581.2-583.0.
50. Omaha World Herald Fireworks
    Sponsor: Omaha Royals.
    Dates: Either the 3rd or 4th day of July.
    Regulated Area: Missouri River miles 612.1-613.9.
51. Riverfest--St. Charles
    Sponsor: City of St. Charles.
    Dates: July 3rd & 4th.
    Regulated Area: Missouri River miles 28.2-28.8.
52. Red White and Boom
    Sponsor: Davenport One Chamber.
    Dates: Either the 3rd or 4th day of July.
    Regulated Area: Upper Mississippi River mile 482.0-483.0.
53. Fair of St. Louis
    Sponsor: Fair St. Louis.
    Dates: Two days between the 1st and 4th of July.
    Regulated Area: Upper Mississippi River miles 179.2-180.0.
54. Louisiana July 4th Fireworks
    Sponsor: Louisiana Chamber of Commerce.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 282.0-283.0.
55. John E. Curran Fireworks
    Sponsor: John E. Curran.
    Dates: Either the 3rd or 4th day of July.
    Regulated Area: Lake of the Ozarks mile 8.9-9.1.
56. Nauvoo 4th of July
    Sponsor: Nauvoo Chamber of Commerce.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 375.0-376.0.
57. Red White and Boom Peoria
    Sponsor: JMP Radio.
    Dates: July 4th.
    Regulated Area: Illinois River miles 162.5-162.1.
58. Stillwater 4th of July
    Sponsor: City of Stillwater/St. Croix Events.
    Dates: July 4th.
    Regulated Area: St. Croix River miles 22.9-23.5.
59. Minneiska 4th of July
    Sponsor: City of Minneiska.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River mile 742.5.-743.5.
60. Fort Madison 4th of July
    Sponsor: City of Fort Madison.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River mile 383.0-384.0.
61. Lake City 4th of July Fireworks
    Sponsor: Lake City Chamber of Commerce.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 772.4-772.8.
62. Hermann 4th of July
    Sponsor: Hermann Chamber of Commerce
    Dates: July 4th.
    Regulated Area: Missouri River miles 98.0-99.0.
63. Muscatine 4th of July
    Sponsor: Greater Muscatine Chamber of Commerce.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 455.0-456.0.
64. National Tom Sawyer Days
    Sponsor: Hannibal JayCees.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 308.0-309.0.

65. Mike Herrington Fireworks
    Sponsor: Mike Herrington.
    Dates: July 4th.
    Regulated Area: Lake of the Ozarks miles 1.5-2.5.
66. Riverfest, La Crosse
    Sponsor: Riverfest, Inc.
    Dates: 4 days during the 1st or 2nd week of July.
    Regulated Area: Upper Mississippi River miles 697.5-698.5.
67. Salute to America
    Sponsor: Salute to America Foundation, Inc.
    Dates: July 4th.
    Regulated Area: Missouri River miles 143.0-143.5.
68. Grafton Chamber 4th of July Fireworks
    Sponsor: Grafton Chamber of Commerce.
    Dates: July 4th.
    Regulated Area: Illinois River miles 0.5-1.5.
69. Parkville 4th of July Fireworks
    Sponsor: Main Street Parkville Assoc.
    Dates: July 4th.
    Regulated Area: Missouri River miles 377.2-378.2.
70. Harrah's Fireworks Extravaganza
    Sponsor: Harrah's Casino and Hotel.
    Dates: July 4th.
    Regulated Area: Missouri River miles 614.8-615.8.
71. Hooligan Bay Fireworks Display
    Sponsor: Hooligan Bay Resort.
    Dates: July 4th.
    Regulated Area: Lake of the Ozarks miles 37.5-38.5.
72. Tan-Tar-A 4th of July Fireworks
    Sponsor: Tan-Tar-A Resort.
    Dates: July 4th.
    Regulated Area: Lake of the Ozarks miles 25.5-26.5.
73. Red, White and Boom Minneapolis
    Sponsor: Minneapolis Park and Recreation Board.
    Dates: July 4th.
    Regulated Area: Upper Mississippi River miles 853.5-854.5.
74. Chillicothe 4th of July
    Sponsor: Chillicothe 4th of July.
    Dates: July 4th.
    Regulated Area: Illinois River miles 179.1-180.1.
75. Lodge of the Four Seasons 4th of July
    Sponsor: Lodge of the Four Seasons.
    Dates: July 4th.
    Regulated Area: Lake of the Ozarks miles 13.5-14.5.
76. Gravois Mills Fireworks
    Sponsor: Town of Gravois.
    Dates: One day during the 1st week of July.
    Regulated Area: Lake of the Ozarks miles 9.5-10.5.
77. Live on the Levee
    Sponsor: Fair St. Louis.
    Dates: Friday and Saturday of every weekend from the 2nd week of
     July until the 2nd week in August.
    Regulated Area: Upper Mississippi River miles 179.2-180.0.
78. Prairie du Chien Area Chamber Fireworks
    Sponsor: Prairie du Chien Area Chamber of Commerce.
    Dates: One day during the 2nd weekend of July.
    Regulated Area: Upper Mississippi River miles 633.5-634.5.
79. Clinton Riverboat Days
    Sponsor: Clinton Riverboat Days.
    Dates: Two days during the 2nd weekend of July.
    Regulated Area: Upper Mississippi River miles 518.0-519.0.
80. Stars and Stripes River Day
    Sponsor: Naturally Guttenberg.
    Dates: One day during the 2nd weekend of July.
    Regulated Area: Upper Mississippi River miles 614.5-615.5.
81. Sioux City Rivercade
    Sponsor: Rivercade Association.
    Dates: One day during the 3rd week in July.
    Regulated Area: Missouri River miles 731.7-732.7.
82. Lumberjack Days
    Sponsor: St. Croix Events.
    Dates: Four days during the 3rd week in July.
    Regulated Area: St. Croix River miles 22.9-28.5.
83. Prairie Air Show
    Sponsor: Prairie Airshow, Inc.

    Dates: One day during the 2nd weekend in July.
    Regulated Area: Illinois River miles 161.5-162.5.
84. Aquatennial Power Boat Grand Prix
    Sponsor: Champboat Series LLC.
    Dates: Two days during the 3rd weekend in July.
    Regulated Area: Upper Mississippi River miles 854.8-855.8.
85. Target Aquatennial Fireworks
    Sponsor: Marketing Minneapolis, LLC.
    Dates: One day during the 3rd weekend in July.
    Regulated Area: Upper Mississippi River miles 853.2-854.2.
86. Rivertown Days
    Sponsor: Hasting Riverboat Days.
    Dates: Two days during the 3rd weekend in July.
    Regulated Area: Upper Mississippi River miles 812.0-815.3.
87. Cassville Twin-o-Rama
    Sponsor: Cassville Twin-O-Rama.
    Dates: One day during the 3rd weekend in July.
    Regulated Area: Upper Mississippi River mile 606.0-607.0.
88. Amelia Earhart Festival
    Sponsor: Amelia Earhart Festival Committee.
    Dates: The 3rd weekend in July.
    Regulated Area: Missouri River miles 422.0-424.5.
89. River City Days
    Sponsor: River City Days Association.
    Dates: Two days during the 1st week in August.
    Regulated Area: Upper Mississippi River miles 791.0-792.0.
90. New Piasa Chautaqua
    Sponsor: New Piasa Chautaqua
    Dates: One day during the 1st weekend in August.
    Regulated Area: Upper Mississippi River miles 214.5-215.5.
91. Great River Tug
    Sponsor: Tug Committee.
    Dates: Two days during the 2nd weekend in August.
    Regulated Area: Upper Mississippi River miles 497.2-497.6.
92. Evansville Day Drag Boat Race
    Sponsor: St. Louis Drag Boat Association.
    Dates: Two days during the 2nd weekend in August.
    Regulated Area: Kaskaskia River miles 10.0-11.0.
93. Lansing Fish Days
    Sponsor: Lansing Lions Club.
    Dates: Two days during the 2nd weekend in August.
    Regulated Area: Upper Mississippi River miles 662.5-663.8.
94. Lake Rescue Shoot Out
    Sponsor: Lake Rescue Shoot Out INC.
    Dates: Two days during the 4th weekend in August.
    Regulated Area: Lake of the Ozarks miles 21.0-23.0.
95. Tan-Tar-A Fireworks
    Sponsor: Tan-Tar-A Resort.
    Dates: One day during the 1st weekend in September.
    Regulated Area: Lake of the Ozarks miles 025.5-026.5.
96. Mike Herrington Labor Day Fireworks
    Sponsor: Mike Herrington.
    Dates: One day during the 1st weekend in September.
    Regulated Area: Lake of the Ozarks miles 001.5-002.5.
97. Lodge of the Four Seasons
    Sponsor: Lodge of the Four Seasons.
    Dates: One day during the 1st weekend in September.
    Regulated Area: Lake of the Ozarks miles 13.5-14.5.
98. First City Festival
    Sponsor: Leavenworth Main Street Program.
    Dates: Two days during the 2nd weekend in September.
    Regulated Area: Missouri River miles 397.0-398.0.
99. Rodeo Cup
    Sponsor: Old Fort Yacht Club.
    Dates: One day during the 2nd weekend in September.
    Regulated Area: Upper Mississippi River miles 374.0-375.0.
100. New Athens Drag Boat Race
    Sponsor: St. Louis Drag Boat Association.
    Dates: Two days during the 2nd weekend in September.
    Regulated Area: Kaskaskia River miles 28.0-29.0.
101. Riverfest
    Sponsor: Riverside Riverfest Committee.
    Dates: Two days during the 3rd weekend in September.
    Regulated Area: Missouri River miles 371.1-371.3.

102. Railroad Days
    Sponsor: Marquette Action Club.
    Dates: One day during the 3rd weekend in September.
    Regulated Area: Upper Mississippi River miles 634.0-635.0.
103. Missouri Governor's Cup
    Sponsor: Valley Sailing Club.
    Dates: Two days during the 1st weekend in October.
    Regulated Area: Upper Mississippi River miles 211.0-212.0.

                   III. SECTOR LOWER MISSISSIPPI RIVER

104. Memphis in May Canoe & Kayak Race
    Sponsor: Outdoors, Inc.
    Date: The 1st or 2nd Saturday in May.
    Regulated Area: Lower Mississippi River miles 735.5-738.5, Memphis,
     TN.
105. Memphis in May Sunset Symphony Fireworks Display
    Sponsor: Memphis in May International Festival, Inc.
    Date: The Saturday before Memorial Day.
    Regulated Area: Lower Mississippi River miles 735.0-736.0, Memphis,
     TN.
106. Riverfest, Little Rock, Arkansas
    Sponsor: Riverfest, Inc.
    Date: The Sunday before Memorial Day.
    Regulated Area: Arkansas River miles 118.8-119.5, Main Street
     Bridge, Little Rock, AR.
107. Riverfest Fireworks Display
    Sponsor: Old Fort Riverfest Committee.
    Date: Either the 2nd or 3rd Saturday in June.
    Regulated Area: Arkansas River miles 297.0-298.0, Fort Smith, AR.
108. Fourth of July Fireworks
    Sponsor: Memphis Center City Commission.
    Date: July 4th.
    Regulated Area: Lower Mississippi River miles 735.5-736.5, Mud
     Island, Memphis, TN.
109. Pops on the River Fireworks Display
    Sponsor: Arkansas Democrat-Gazette.
    Date: July 4th.
    Regulated Area: Arkansas River miles 118.8-119.5 near the Main
     Street Bridge, Little Rock, AR.
110. Uncle Sam Jam Fireworks, Alexandria, LA
    Sponsor: Champion Broadcasting of Alexandria.
    Date: July 4th.
    Regulated Area: Red River miles 83.0-87.0, Alexandria, LA.

                        IV. SECTOR CORPUS CHRISTI

111. Buccaneer Days Fireworks Display
    Sponsor: Buccaneer Commission, Inc.
    Date: The 3rd or 4th Friday in April.
    Regulated Area: Downtown waterfront, all waters inside Corpus
     Christi Marina breakwater, Corpus Christi Bay, TX.
112. Corpus Christi 4th of July Fireworks Display
    Sponsor: Buccaneer Commission, Inc.
    Date: July 4th.
    Regulated Area: Downtown waterfront, all waters inside Corpus
     Christi Marina breakwater, Corpus Christi Bay, TX.
113. City of Port Aransas 4th of July Fireworks Display
    Sponsor: City of Port Aransas.
    Date: July 4th.
    Regulated Area: all waters within a 600-foot radius of a point
     halfway between Port Aransas Harbor Daybeacon 2 to Port Aransas
     Ferry Landing in the Corpus Christi Ship Channel, Port Aransas, TX.
114. Bayfest Fireworks Display
    Sponsor: Bayfest, Inc.
    Date: The last Saturday in September.
    Regulated Area: Downtown waterfront, all waters inside Corpus
     Christi Marina breakwater, Corpus Christi Bay, TX.
115. Harbor Lights
    Sponsor: City of Corpus Christi.
    Date: The 1st Saturday in December.
    Regulated Area: Downtown waterfront, all waters inside Corpus
     Christi Marina breakwater, Corpus Christi Bay, TX.
116. Wendell Family Fireworks
    Sponsor: City of Rockport.
    Date: July 4th.
    Regulated Area: all waters within a 700-foot radius of the northeast
     point of Rockport Beach Park in Rockport, TX.

                       V. SECTOR HOUSTON-GALVESTON

117. Port Arthur Fourth of July Fireworks Demonstration
    Sponsor: The City of Port Arthur and Lamar State College.
    Date: July 4th.
    Regulated Area: All waters of the Sabine-Neches Canal between
     Intracoastal Waterway miles 284 and 285.
118. Neches River Festival and Fireworks, Beaumont, TX
    Sponsor: Port Neches Chamber of Commerce.
    Date: Two Days during either the 2nd or 3rd weekend in May.
    Regulated Area: All waters of the Bessie Heights canal adjacent to
     Port Neches between the northern boundary at 30[deg]00'00'' N and
     the southern boundary at 29[deg]59'42'' N.

119. Contraband Days Fireworks Display
    Sponsor: Contraband Days Festivities, Inc.
    Date: The 2nd Saturday in May.
    Regulated Area: In Lake Charles a 500-foot radius from the fireworks
     barge anchored at approximate position 30[deg]13'05'' N,
     093[deg]13'42'' W, Lake Charles, LA.
120. Neches River 4th of July Celebration
    Sponsor: City of Beaumont.
    Date: July 4th.
    Regulated Area: At River Front Park in Beaumont, TX, the Neches
     River from the Trinity Industries Dry Dock to the northeast corner
     of the Port of Beaumont's dock Number 5.
121. National Safe Boating Week
    Sponsor: Houston Power Squadron.
    Date: The last weekend in May or the first weekend in June.
    Regulated Area: Clear Creek Channel from Light 2 up to, but not
     including, the South Shore Harbor Marina.
122. Sylvan Beach Fireworks Display, Sylvan Beach, Houston, TX
    Sponsor: City of LaPorte.
    Date: One day in the end of June or early July.
    Regulated Area: An east-west oriented square extending 600 feet
     North, 600 feet South; 600 feet East, and 600 feet West centered
     around the fireworks launch area on the bank of Galveston Bay in
     the vicinity of the Sylvan Beach Bait Shop, Sylvan Beach, La Porte,
     TX.
123. Clear Lake Fireworks Display, Clear Lake, Houston, TX
    Sponsor: Clear Lake Chamber of Commerce.
    Date: July 4th.
    Regulated Area: An east-west oriented rectangle extending 500 feet
     East, 500 feet West; 1000 feet North, and 1000 feet South, centered
     around the fireworks barge at Light 19 on Clear Lake, Houston, TX.
124. Blessing of the Fleet
    Sponsor: Clear Lake Elks Club.
    Date: The 1st Sunday in August.
    Regulated Area: Clear Creek Channel from Light 2 up to, but not
     including, the South Shore Harbor Marina.
125. Galveston Harbor Lighted Boat Parade
    Sponsor: Historic Downtown/Strand Partnership.
    Date: The last Saturday in November.
    Regulated Area: Galveston Channel from Pier 9 to the Pelican Island
     Bridge.
126. Christmas Boat Parade on Clear Lake
    Sponsor: Clear Lake Area Chamber of Commerce.
    Date: The 2nd Saturday in December.
    Regulated Area: Clear Lake, Texas from South Shore Harbor Marina
     down Clear Lake Channel to Clear Creek Channel Light 2.
127. Kemah Board Walk Summer Season Fireworks Display, Kemah, TX
    Sponsor: Kemah Boardwalk.
    Date: July 4th and every Friday night in June and July.
    Regulated Area: Clear Creek Channel, including the area within an
     840-foot radius of the fireworks barge on the south side of the
     channel, 100 ft off of Kemah Boardwalk in Galveston, TX.

                         VI. SECTOR NEW ORLEANS

128. Rivertown Christmas Festival
    Sponsor: City of Port Allen.
    Date: The 3rd Saturday in December.
    Regulated Area: Located on Levee Batture in the vicinity of the Old
     Ferry Landing, the Lower Mississippi River from mile marker 230-
     231.
129. Donaldsonville Fireworks Display
    Sponsor: Donaldsonville Tourism Commission.
    Date: December 31st.
    Regulated Area: Located on the Levee Batture, all waters of the
     Lower Mississippi River from mile marker 175-176.
130. New Orleans New Years Eve
    Sponsor: Mardi Gras World, Inc.
    Date: December 31st.
    Regulated Area: In vicinity of Jackson Square, the Lower Mississippi
     River from miles 94-95.
131. Lundi Gras River Parade and Fireworks Display
    Sponsor: (King REX and King ZULU) New Orleans RiverWalk Marketing
     Group and ZULU Social Aid and Pleasure Club.
    Date: Lundi Gras (the Monday before Mardi Gras).
    Regulated Area: The Lower Mississippi River from mile 93 to mile 96,
     New Orleans, LA.
132. Independence Day Celebration
    Sponsor: Saint John the Baptist Parish.
    Date: July 3rd.
    Regulated Area: In vicinity of Saint Peter's Church, all waters of
     the Lower Mississippi River miles 138.5-139.5, Reserve, LA.
133. Donaldsonville Fireworks Display
    Sponsor: Donaldsonville Tourism Commission.
    Date: July 3rd.
    Regulated Area: In the vicinity of Crescent Park, the Lower
     Mississippi River miles 175-176, Donaldsonville, LA.
134. Independence Day Celebration
    Sponsor: Saint Charles Parish Fireworks.
    Date: July 3rd.
    Regulated Area: Levee Batture, in the vicinity of I-310 Bridge, the
     Lower Mississippi River miles 121-122, Luling, LA.
135. Independence Day Celebration (Dueling Barges)
    Sponsor: Riverfront Marketing Group.
    Date: July 4th
    Regulated Area: In vicinity of Jackson Square and Spanish Plaza, the
     Lower Mississippi River from miles 94.3-95.3.

136. Independence Day Celebration
    Sponsor: WBRZ-TV, Baton Rouge, LA.
    Date: July 4th.
    Regulated Area: In the vicinity of the USS KIDD, the Lower
     Mississippi River from miles 228.8-229.8.
137. Fourth of July Star-Spangled Celebration
    Sponsor: USS KIDD Veterans Memorial Baton Rouge, LA.
    Date: July 4th.
    Regulated Area: In the vicinity of 305 South River Road, the Lower
     Mississippi River miles 229.4-230.0, Baton Rouge, LA.
138. Independence Day Celebration
    Sponsor: Boomtown Casino.
    Date: July 4th.
    Regulated Area: In the vicinity of Boomtown Casino, Harvey Canal
     miles 4-5.
139. Independence Day Celebration
    Sponsor: City of Morgan City.
    Date: July 4th.
    Regulated Area: Morgan City Port Allen Route miles 4-5.
140. Louisiana Shrimp and Petroleum Festival
    Sponsor: City of Morgan City.
    Date: The 1st Sunday in September.
    Regulated Area: Lower Atchafalaya River between the Berwick Bay
     Southern Pacific Railroad Bridge and 1/4 mile north of the Highway
     182 Bridge on the Lower Atchafalaya River.

                           VII. SECTOR MOBILE

141. Seroma's 4th of July
    Sponsor: Seroma's 4th of July.
    Date: July 4th.
    Regulated Area: All waters within a 200-foot radius of
     30[deg]24'27'' N/ 087[deg]2'27'' W near Seville Harbor in
     Pensacola, FL.
142. South Georgia Showdown
    Sponsor: Flint River Racers.
    Date: One day during the last weekend in August or the first weekend
     in September.
    Regulated Area: The Flint River from mile 21.8 to 22.6 near
     Bainbridge, GA.
143. Thunder on the Gulf
    Sponsor: Gulf Coast Power Boat Association.
    Date: 2 Days during the 3rd weekend in August.
    Regulated Area: The waters off Orange Beach, Florida enclosed by a
     line starting at a point on the shore at approximately
     30[deg]15'38'' N/087[deg]36'45'' W, then south to 30[deg]14'18'' N/
     087[deg]36'45'' W, then east, roughly parallel to the shore to
     30[deg]15'14'' N/087[deg]33'36'' W, then north to a point on the
     shore at approximately 30[deg]16'19'' N/087[deg]33'36'' W, then
     west along the shore back to the starting point.
144. [RESERVED]
145. Christmas on the River
    Sponsor: Demopolis Chamber of Commerce.
    Date: The 1st Saturday in December from 6 p.m. to 8 p.m.
    Regulated Area: Tombigbee River from Lock 4 to Caldwell Landing in
     Demopolis, AL.
146. Christmas by the River
    Sponsor: Moss Point Active Citizens.
    Date: The 1st Saturday in December from 5:00 p.m. to 7:30 p.m.
    Regulated Area: Escataba River from the route 613 bridge east to the
     Moss Point City Docks.
147. Christmas on the Water
    Sponsor: Biloxi Bay Chamber of Commerce.
    Date: The 1st Saturday in December.
    Regulated Area: Biloxi Channel from mile 5 to mile 28, Biloxi, MS.
148. Isle of Capri Anniversary Celebration
    Sponsor: River Boat Corporation (Isle of Capri).
    Date: August 1st from 8:45 p.m. to 10:00 p.m.
    Regulated Area: All waters within 500 feet of 30[deg]23'32'' N
     088[deg]51'26'' W (south of the Biloxi Ocean Springs Bridge in
     Biloxi, Mississippi).
149. Billy Bowlegs Pirate Festival
    Sponsor: Greater Fort Walton Beach Chamber of Commerce.
    Date: One day during the 1st weekend in June.
    Regulated Area: In Santa Rosa Sound, the area East of the Brooks
     Bridge to Fort Walton Yacht Club at Smack Point and the area west
     of the Brooks Bridge to St. Simon's Church.
150. Dauphin Island Race
    Sponsor: Fairhope, Lake Forest, Mobile, and Buccaneer Yacht Clubs.
    Date: One day during the next-to-last or last weekend in April.
    Regulated Area: Mobile Bay from the Middle Bay Light to Marker 37,
     Mobile, AL.
151. Big River Blast
    Sponsor: City of Chattahoochee.
    Date: One day during the 3rd weekend in April from 11:00 a.m. to
     6:00 p.m.
    Regulated Area: The Appalachicola River from the dam to 1/4 mile
     south of the dam, Chattahoochee, FL.
152. Chattahoochee Challenge
    Sponsor: City of Chattahoochee.
    Date: One day during the last weekend in March from 11:00 a.m. to
     6:00 p.m. CST.
    Regulated Area: The Appalachicola River from the dam to 1/2 mile
     south of the dam, Chattahoochee, FL.
153. Harbor Walk Fireworks Display
    Sponsor: Legendary Incorporated.
    Date: Memorial Day, Labor Day and every Thursday evening from May to
     September from 8:00 p.m. to 8:30 p.m.
    Regulated Area: In East Pass, a 560-foot safety radius around the
     fireworks barge and push boat, Destin, FL.

154. Smoking the Sound
    Sponsor: Biloxi Bay Chamber of Commerce.
    Date: Two days between the 4th week in March and the 2nd week in
     April from 9:00 a.m. to 6:00 p.m. CST.
    Regulated Area: Biloxi Ship Channel from buoy 2 to 35.
155. Christmas Afloat
    Sponsor: Christmas Afloat Incorporated.
    Date: Either the 2nd or 3rd Saturday in December.
    Regulated Area: A portion of the Black Warrior River from the U.S.
     Highway 82 Bypass Bridge to mile 340 near Tuscaloosa, Alabama.
156. Air Sea Rescue
    Sponsor: Gulf Coast Shows.
    Date: One day during the 3rd or 4th weekend in February.
    Regulated Area: On the Mobile River the area 1/2 mile upriver and 1/
     2 mile down river from the Mobile Convention Center.
157. Blessing of the Fleet
    Sponsor: St. Michael's Catholic Church.
    Date: The 1st Sunday in June.
    Regulated Area: The Biloxi Channel from Daybeacon 1 to Buoy
     34, Biloxi, Mississippi.
158. Blessing of the Fleet
    Sponsor: St. Margaret Church.
    Date: Either the 2nd or 3rd Sunday in May.
    Regulated Area: Entire Bayou La Batre, Bayou La Batre, AL.
159. Flag Day Parade
    Sponsor: Warrior River Boating Association.
    Date: July 3rd.
    Regulated Area: Warrior River Bankhead Lake River miles 368.4-386.4,
     Cottondale, AL.
160. Blue Angels Air Show
    Sponsor: Naval Air Station Pensacola.
    Date: One day during the 2nd weekend in July.
    Regulated Area: All waters south of the Pensacola barrier islands
     within 5 nautical miles of 30[deg]19'35'' N/ 087[deg]08'29'' W, a
     point approximately 500 yards south of the Pensacola Beach water
     tower at the foot of the Pensacola fixed bridge adjacent to Little
     Sabine Bay, Pensacola, FL.
161. Boat Parade of Lights
    Sponsor: City of Panama City/ St. Andrews Project.
    Date: The 2nd Saturday in December from 5:30 p.m. to 7:30 p.m.
    Regulated Area: St. Andrews Bay from St. Andrews Bay Yacht Club to
     St. Andrews Bay Marina in Pensacola, FL.
162. Mardi Gras Boat Parade
    Sponsor: Gulf Shores Homeport Marina.
    Date: The Monday before Mardi Gras.
    Regulated Area: GIWW Pen Mobile Channel in Gulf Shores, AL from the
     Wharf Orange Beach, west to Oyster Bay and then east to Homeport
     Marina.
    Wharf
    Warf
163. Blessing of the Fleet
    Sponsor: Panama City Marina.
    Date: The last Saturday in March.
    Regulated Area: In the southeast basin of Panama City Marina located
     at 30[deg]09'06'' N/085[deg]39'51'' W, all waters between Harrison
     Avenue and the seawall.
164. Mobile Boat and Sportsman Show
    Sponsor: Gulf Coast Shows.
    Date: Four days over either the 3rd or 4th weekend of February.
    Regulated Area: On the Mobile River the area 1/2 mile upriver and 1/
     2 mile down river from the Mobile Convention Center, Mobile, AL.
165. Bass Tournament Weigh-In
    Sponsor: Gulf Coast Shows.
    Date: Two days during the 3rd or 4th weekend in February.
    Regulated Area: On the Mobile River the area 1/2 mile upriver and 1/
     2 mile down river from the Mobile Convention Center, Mobile, AL.
166. Water Ski Demonstration
    Sponsor: Gulf Coast Shows.
    Date: One day during the 3rd or 4th weekend in February.
    Regulated Area: On the Mobile River the area 1/2 mile upriver and 1/
     2 mile down river from the Mobile Convention Center, Mobile, AL.
------------------------------------------------------------------------

    Dated: March 30, 2009.
J.R. Whitehead,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. E9-11224 Filed 5-13-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66169-66173]
[FR Doc No: 2021-25379]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2020-N-1088]

Microbiology Devices; Reclassification of Nucleic Acid-Based
Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic
Acid-Based Hepatitis C Virus Ribonucleic Acid Tests

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify nucleic acid-based hepatitis C
virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative
or quantitative detection or genotyping of HCV RNA, postamendments
class III devices (product codes MZP and OBF), into class II (general
controls and special controls), subject to premarket notification. FDA
is renaming and codifying these devices under the classification
regulation named ``nucleic acid-based hepatitis C virus (HCV)
ribonucleic acid tests.'' FDA is also identifying the special controls
that the Agency believes are necessary to provide a reasonable
assurance of safety and effectiveness of these devices.

DATES: This order is effective December 22, 2021.

FOR FURTHER INFORMATION CONTACT: Silke Schlottmann, Division of
Microbiology Devices, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3258,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (general and special controls), and class III
(general controls and premarket approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until: (1) FDA
reclassifies the device into class I or II or (2) FDA issues an order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. FDA determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807, subpart E (21 CFR part 807, subpart E).
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA, acting by administrative
order, can reclassify the device into class I or II on its own
initiative, or in response to a petition from the manufacturer or
importer of the device. To change the classification of the device, the
proposed new class must have sufficient regulatory controls to provide
a reasonable assurance of the safety and effectiveness of the device
for its intended use.
    FDA relies upon ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the
classification process to determine the level of regulation for
devices. To be considered in the reclassification process, the ``valid
scientific evidence'' upon which the Agency relies must be publicly
available (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c))).
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA) (see section 520(c) of the FD&C
Act).
    FDA published a proposed order in the Federal Register of April 2,
2020 (85 FR 18483), to reclassify nucleic acid-based HCV RNA devices
intended for the qualitative or quantitative detection or genotyping of
HCV RNA, postamendment class III devices, into class II (general
controls and special controls), subject to premarket notification. FDA
has considered the information available to the Agency, including the
deliberations of the March 22, 2018, Microbiology Devices Panel (2018
Panel), and comments from the public docket and has determined that
there is sufficient information to establish special controls to
effectively mitigate the risks to health identified in section V of the
proposed order, and that these special controls, together with general
controls, provide a reasonable assurance of safety and effectiveness
when applied to nucleic acid-based HCV RNA devices intended for the
qualitative or quantitative detection or genotyping of HCV RNA.
    Therefore, in accordance with section 513(f)(3) of the FD&C Act,
FDA, on its own initiative, is issuing this final order to reclassify
nucleic acid-based HCV RNA devices intended for the qualitative or
quantitative detection or genotyping of HCV RNA from class III to class
II (general and special controls).\1\
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretation of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22) and the Document Drafting Handbook.
---------------------------------------------------------------------------

II. Comments on the Proposed Order

    On April 2, 2020, FDA published in the Federal Register a proposed
order to reclassify nucleic acid-based HCV RNA devices intended for the
qualitative or quantitative detection or genotyping of HCV RNA from
class III to class II, subject to premarket notification. The comment
period on the proposed order closed on June 1, 2020. In response to the
proposed order, FDA received comments from industry, healthcare
associations, public health departments, and individual consumers by
the close of the comment period, some of which contained one or more
comments on one or more issues. We describe and respond to the comments
in this section of the document. Certain comments are grouped based on
common themes; we grouped similar comments together under the same
number and listed them numerically.

    The order of response to the commenters is purely for
organizational purposes and does not signify the comment's value or
importance nor the order in which comments were received. Please note
that in some cases we separated different issues discussed by the same
commenter and designated them as distinct comments for purposes of our
responses.
    (Comment 1) FDA received numerous comments in favor of the proposed
reclassification of nucleic acid-based HCV RNA devices intended for the
qualitative or quantitative detection or genotyping of HCV RNA from
class III to class II with special controls. Commenters stated they
believed that special controls, along with general controls, could
provide a reasonable assurance of the safety and effectiveness of these
devices. In addition, they believed that the decreased regulatory
burden resulting from the reclassification could encourage further
development of, and provide patients more timely access to, these
devices. Overall, there was a general consensus among the commenters
that the proposed special controls are necessary and sufficient to
mitigate the risks to health of patients presented by these devices and
to provide reasonable assurance of the safety and effectiveness of
these devices.
    (Response 1) Based on the evidence considered, comments received in
response to the proposed order, and deliberations of the 2018 Panel,
FDA agrees with the commenters that reclassification of nucleic acid-
based HCV RNA devices for the qualitative or quantitative detection or
genotyping of HCV RNA from class III into class II and that special
controls, in addition to general controls, can provide a reasonable
assurance of the safety and effectiveness of these devices. In
addition, FDA expects that the reclassification of these devices would
enable more manufacturers to develop them such that patients would
benefit from increased access to safe and effective tests.
    (Comment 2) One comment objected to the proposed reclassification
of these devices from class III into class II on the basis that the
commenter was not provided adequate notification of the proposed
reclassification.
    (Response 2) FDA disagrees with this comment as FDA provided notice
of our proposed reclassification of these devices with the publication
of the proposed order in the Federal Register on April 2, 2020, in
accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860.
In addition, as discussed further in the proposed order, a public
meeting of the 2018 Panel was held where FDA discussed the possible
reclassification of nucleic acid-based HCV RNA tests and the Panel
members agreed unanimously with the proposal.
    (Comment 3) Several commenters had questions about the scope of the
proposed reclassification order. Several commenters noted that the
proposed reclassification order identified these devices as nucleic-
acid based HCV RNA tests for prescription use and suggested that the
reclassification order should also include tests intended for over-the-
counter (OTC) use. In addition, one commenter suggested that FDA's
reclassification order should also include HCV antigen tests, tests for
hepatitis A and hepatitis B, and also that the reclassification should
include other specimen types for nucleic acid-based HCV RNA tests
beyond those identified in the proposed order (e.g., urine or saliva).
    (Response 3) These comments are beyond the scope of FDA's proposed
reclassification order, which applies only to nucleic acid-based HCV
RNA tests that have been previously approved by FDA. FDA has not
approved any nucleic acid-based HCV RNA tests intended for OTC use, and
FDA believes that a nucleic acid-based HCV RNA test intended for OTC
use would be a new type of device not previously classified based on
the criteria at section 513(a)(1) of the FD&C Act and, as a result,
such postamendments device would be automatically classified into class
III by operation of section 513(f)(1) of the FD&C Act.
    Similarly, to date, FDA has only approved nucleic acid-based HCV
RNA tests intended for use with human serum or plasma, and new specimen
types are beyond the scope of FDA's proposed reclassification order.
    (Comment 4) Several commenters expressed support of FDA's proposal
to rename these devices from ``nucleic acid-based hepatitis C virus
(HCV) ribonucleic acid (RNA) assay devices'' to ``nucleic acid-based
hepatitis C virus (HCV) ribonucleic acid (RNA) tests.'' These
commenters believed that the new name for these devices made clear that
these are diagnostic tests and is consistent with the naming of similar
diagnostic devices.
    (Response 4) FDA believes that the new identification name of these
devices--``nucleic acid-based hepatitis C virus (HCV) ribonucleic acid
(RNA) tests''--is both understandable to consumers and industry and is
consistent with the naming of similar diagnostic devices and agrees
with these commenters. As discussed further below in section III, FDA
on its own initiative has revised the device identification of nucleic-
acid based HCV RNA to be codified in Sec.  866.3170(a) (21 CFR
866.3170(a)).
    (Comment 5) One commenter suggested that the proposed special
control requiring cross-reactivity studies may not be necessary and
suggested instead that interfering substance studies be conducted
according to ``CLSI-EP-7-A2: Interference Testing in Clinical
Chemistry: Approved Guideline--Second Edition'' (Ref. 1).
    (Response 5) FDA disagrees with this comment and believes that the
special control requiring cross-reactivity studies that include samples
from HCV RNA negative subjects with other causes of liver disease,
including autoimmune hepatitis, alcoholic liver disease, chronic
hepatitis B virus, primary biliary cirrhosis, and nonalcoholic
steatohepatitis, when applicable, is necessary to provide a reasonable
assurance of the safety and effectiveness of these devices (see Sec.
866.3170(b)(2)(iv)). FDA also believes that specifying a standard
explicitly as part of the special controls that manufacturers must
follow is not necessary and would prohibit the use of a new standard in
the event that the version of the standard specified in the special
controls is revised and/or updated.
    (Comment 6) One commenter suggested that FDA provide additional
details regarding the study design and analysis required for devices
intended for the quantitative detection of HCV RNA by the special
control in Sec.  866.3170(b)(4)(C). In addition, the commenter
requested clarification on the requirement for clinical studies for
nucleic-acid based HCA RNA tests intended for Point of Care (PoC) use
and inquired whether the sample size for such studies should be larger
than for the other clinical studies required by the special controls.
    (Response 6) FDA disagrees with this comment and does not believe
that additional specificity is required to provide a reasonable
assurance of the safety and effectiveness of these devices because the
appropriate sample size for a required study may be influenced by the
technology at issue and/or type of device under review.
    FDA recommends that device manufacturers interested in obtaining
FDA feedback on their study design submit a pre-submission (Ref. 2). In
addition, FDA publishes our decision summaries for previously approved
or cleared devices for in vitro diagnostic testing on our website and
these summaries can be useful aids for

manufacturers to obtain information on the study designs used to
support the marketing authorizations of other nucleic-acid based HCV
RNA tests (Refs. 3 and 4).

III. The Final Order

    Based on the information discussed in the preamble to the proposed
order (April 2, 2020), the comments received for the proposed order,
the 2018 Panel delibrations (Ref. 5), and FDA's experiences over the
years in reviewing these devices, FDA concludes that special controls,
in conjunction with general controls, will provide a reasonable
assurance of the safety and effectiveness of nucleic-acid based HCV RNA
tests. FDA is adopting its findings under section 513(f)(3) of the FD&C
Act, as published in the preamble to the proposed order. FDA is issuing
this final order to reclassify nucleic acid-based HCV RNA devices
intended for the qualitative or quantitative detection or genotyping of
HCV RNA from class III to class II, and to establish special controls
by revising 21 CFR part 866. In this final order, the Agency has
identified the special controls under section 513(a)(1)(B) of the FD&C
Act that, together with general controls, provide a reasonable
assurance of the safety and effectiveness of these devices.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide a reasonable assurance of the
safety and effectiveness of nucleic-acid based HCV RNA tests.
Therefore, these devices are not exempt from premarket notification
requirements. Persons who intend to market a new nucleic-acid based HCV
RNA device intended for the qualitative or quantitative detection or
genotyping of HCV RNA must submit to FDA a premarket notification,
obtain clearance, and demonstrate compliance with the special controls
included in this final order, prior to marketing the device.
    These devices are assigned the generic name ``nucleic-acid based
hepatitis C virus ribonucleic acid tests'' and are identified as in
vitro diagnostic devices intended for prescription use as an aid in the
diagnosis of HCV infection in specified populations, and/or as an aid
in the management of HCV-infected patients including guiding the
selection of genotype-specific treatment in individuals with chronic
HCV infection. These tests are intended for use with human serum or
plasma. These tests are not intended for use as a donor screening test
for the presence of HCV antibodies in blood, blood products, or tissue
donors.
    Under this final order, nucleic acid-based HCV RNA tests are
identified as prescription use only devices and as such, nucleic acid-
based HCV RNA tests must satisfy prescription labeling requirements for
in vitro diagnostic products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)).
Under 21 CFR 807.81, the device continues to be subject to 510(k)
requirements.
    As part of the process for issuance of this final order and on its
own initiative, FDA has identified previously approved nucleic-acid
based HCV RNA tests for use as an aid in diagnosis of HCV infection
without prior evidence of HCV antibodies. In this final order, FDA has
revised the device identification of nucleic-acid based HCV RNA tests
to be codified in Sec.  866.3170(a) to clarify that nucleic acid-based
HCV RNA tests can include devices used as an aid for diagnosis of HCV
infection in specified populations without prior evidence of HCV
antibodies because FDA believes that it may be appropriate to use these
devices as a one-step diagnostic assay and in the absence of evidence
of HCV antibodies.

IV. Codification of Orders

    Prior to the amendments in the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) (FDASIA), section 513(e) of the
FD&C Act provided for FDA to issue regulations to reclassify devices.
Although section 513(e), as amended by FDASIA, requires FDA to issue
final orders rather than regulations, it also provides for FDA to
revoke previously issued regulations by order. FDA will continue to
codify classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i), as
amended by FDASIA, in this final order, we are proposing to codify the
classification of nucleic-acid based hepatitis C virus ribonucleic acid
tests in the new Sec.  866.3170, under which nucleic-acid based HCV RNA
tests would be reclassified into class II.

V. Analysis of Environmental Impact

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

VI. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved FDA collections. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in part 807, subpart E have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR parts 801and 809 have been approved under OMB control number
0910-0485; and the collections of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073.

VII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they also are available
electronically at https://www.regulations.gov. References without
asterisks are not on public display at https://www.regulations.gov
because they have copyright restrictions. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

1. Clinical and Laboratory Standards Institute. Interference Testing
in Clinical Chemistry; Approved Guideline--Second Edition. CLSI
document EP07-A2. Wayne, PA: Clinical and Laboratory Standards
Institute; 2005.
*2. ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program--Guidance for Industry and
Food and Drug Administration Staff,'' issued May 7, 2019 (available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program).
*3. FDA's Premarket Approval Database available on FDA's website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.
*4. FDA's 510(k) Premarket Notification Database available on FDA's
website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
*5. Transcript of the FDA Microbiology Devices Panel Meeting, March
22, 2018

(available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM630139.pdf).

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.3170 to subpart D to read as follows:

Sec.  866.3170   Nucleic acid-based hepatitis C virus ribonucleic acid
tests.

    (a) Identification. A nucleic acid-based hepatitis C virus (HCV)
ribonucleic acid (RNA) test is identified as an in vitro diagnostic
device intended for prescription use as an aid in the diagnosis of HCV
infection in specified populations, and/or as an aid in the management
of HCV-infected patients including guiding the selection of genotype-
specific treatment in individuals with chronic HCV infection. The test
is intended for use with human serum or plasma. The test is not
intended for use as a donor screening test for the presence of HCV
antibodies in blood, blood products, or tissue donors.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) For all nucleic acid-based HCV RNA tests, the labeling required
under Sec.  809.10(b) of this chapter must include:
    (i) A prominent statement that the test is not intended for use as
a donor screening test for the presence of HCV RNA from human cells,
tissues, and cellular and tissue-based products.
    (ii) A detailed explanation of the principles of operation and
procedures for performing the assay.
    (iii) A detailed explanation of the interpretation of results.
    (iv) Limitations, which must be updated to reflect current clinical
practice and disease presentation and management. These limitations
must include, but are not limited to, statements that indicate:
    (A) The specimen types for which the device has been cleared and
that use of this test kit with specimen types other than those
specifically cleared for this device may result in inaccurate test
results.
    (B) When applicable, that assay performance characteristics have
not been established in populations of immunocompromised or
immunosuppressed patients or, other populations where test performance
may be affected.
    (C) Test results are to be interpreted by qualified licensed
healthcare professionals in conjunction with the individual's clinical
presentation, history, and other laboratory results.
    (2) For all nucleic acid-based HCV RNA tests, the design
verification and validation must include:
    (i) Detailed device description, including the device components,
ancillary reagents required but not provided, and an explanation of the
device methodology. Additional information appropriate to the
technology must be included such as design of primers and probes,
rationale for the selected gene targets, specifications for amplicon
size, and degree of nucleic acid sequence conservation.
    (ii) For devices with assay calibrators, the design and nature of
all primary, secondary, and subsequent quantitation standards used for
calibration as well as their traceability to a standardized reference
material that FDA has determined is appropriate (e.g., a recognized
consensus standard). In addition, analytical testing must be performed
following the release of a new lot of the standard material that was
used for device clearance or approval, or when there is a transition to
a new calibration standard.
    (iii) Documentation and characterization (e.g., determination of
the identity, supplier, purity, and stability) of all critical reagents
(including nucleic acid sequences for primers and probes) and protocols
for maintaining product integrity.
    (iv) Detailed documentation of analytical performance studies
conducted as appropriate to the technology, specimen types tested, and
intended use of the device, including, but not limited to, limit of
detection (LoD), upper and lower limits of quantitation (ULoQ and LLoQ,
respectively), linearity, precision, endogenous and exogenous
interferences, cross reactivity, carryover, matrix equivalency, and
sample and reagent stability. Samples selected for use in analytical
studies or used to prepare samples for use in analytical studies must
be from subjects with clinically relevant circulating genotypes in the
United States. Cross-reactivity studies must include samples from HCV
RNA negative subjects with other causes of liver disease, including
autoimmune hepatitis, alcoholic liver disease, chronic hepatitis B
virus, primary biliary cirrhosis, and nonalcoholic steatohepatitis,
when applicable. The effect of each claimed nucleic-acid isolation and
purification procedure on detection must be evaluated.
    (v) Risk analysis and management strategies, such as Failure Modes
Effects Analysis and/or Hazard Analysis and Critical Control Points
summaries and their impact on test performance.
    (vi) Final release criteria to be used for manufactured test lots
with appropriate evidence that lots released at the extremes of the
specifications will meet the claimed analytical and clinical
performance characteristics as well as the stability claims.
    (vii) Multisite reproducibility study that includes the testing of
three independent production lots.
    (viii) All stability protocols, including acceptance criteria.
    (ix) Final release test results for each lot used in clinical
studies.
    (x) Analytical sensitivity and specificity of the test must be the
same or better than that of other cleared or approved tests.
    (xi) Lot-to-lot precision studies, as appropriate.
    (3) For devices intended for the qualitative detection of HCV RNA,
in addition to the special controls listed in paragraphs (b)(1) and (2)
of this section, the design verification and validation must include
detailed documentation of performance from a multisite clinical study.
Performance must be analyzed relative to an FDA cleared or approved
qualitative HCV RNA test, or a comparator that FDA has determined is
appropriate. This study must be conducted using appropriate patient
samples, with appropriate numbers of HCV positive and negative samples
in applicable risk categories. Additional genotypes must be validated
using appropriate numbers and types of samples. The samples may be a
combination of fresh and repository samples, sourced from within and
outside the United States, as appropriate. The study designs, including
number of samples tested, must be sufficient to meet the following
criteria:
    (i) Clinical sensitivity of the test must have a lower bound of the
95 percent confidence interval of greater than or equal to 95 percent.
    (ii) Clinical specificity of the test must have a lower bound of
the 95 percent

confidence interval of greater than or equal to 96 percent.
    (4) For devices intended for the quantitative detection of HCV RNA,
the following special controls, in addition to those listed in
paragraphs (b)(1) and (2) of this section, apply:
    (i) Labeling required under Sec.  809.10(b) of this chapter must
include a prominent statement that the test is not intended as a
diagnostic test to confirm the presence of active HCV infection, when
applicable.
    (ii) Design verification and validation must include the following:
    (A) Detailed documentation of the following analytical performance
studies conducted as appropriate to the technology, specimen types
tested, and intended use of the device, including but not limited to:
LoD, ULoQ and LLoQ. LoD, LLoQ, and linearity studies must demonstrate
acceptable device performance with all HCV genotypes detected by the
device.
    (B) Detailed documentation of clinical performance testing from
either:
    (1) A multisite clinical study with an appropriate number of
clinical samples from chronically HCV infected patients in which the
results are compared to an FDA-cleared or approved quantitative HCV RNA
test, or a comparator that FDA has determined is appropriate. This
study must include a sufficient number of HCV positive samples
containing an analyte concentration near the LLoQ to describe
performance at this level. Clinical samples must cover the full range
of the device output and must be consistent with the distribution of
these genotypes in the U.S. population. Clinical samples may be
supplemented with diluted clinical samples for those viral load
concentrations that are not sufficiently covered by natural clinical
specimens, or
    (2) A clinical study with prospectively collected samples
demonstrating clinical validity of the device.
    (C) Detailed documentation of a qualitative analysis near the lower
end of the measuring range demonstrating acceptable performance when
used as an aid in diagnosis.
    (5) For devices intended for HCV RNA genotyping, in addition to the
special controls listed in paragraphs (b)(1) and (2) of this section,
design verification and validation must include the following:
    (i) Detailed documentation of an analytical performance study
demonstrating the LoD for all HCV genotypes detected by the device.
    (ii) Detailed documentation, including results, of a multisite
clinical study that assesses genotyping accuracy (i.e., the proportion
of interpretable results that match with the reference method result)
and the genotyping rate (i.e., the proportion of results that were
interpretable).
    (6) For any nucleic acid-based HCV RNA test intended for Point of
Care (PoC) use, the following special controls, in addition to those
listed in paragraphs (b)(1) and (2) of this section, apply:
    (i) Clinical studies must be conducted at PoC sites.
    (ii) Additional labeling must include a brief summary of the
instructions for use that are appropriate for use in a PoC environment.

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25379 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Page 10201]
[FR Doc No: 2020-03509]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-498, OMB Control No. 3235-0556]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 15b11-1/Form BD-N

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and
Exchange Commission (``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for approval of extension of
the previously approved collection of information provided for in Rule
15b11-1 (17 CFR 240.15b11-1) under the Securities Exchange Act of 1934
(``Exchange Act'') (15 U.S.C. 78a et seq.) and Form BD-N (17 CFR
249.501b).
    Rule 15b11-1 provides that a broker or dealer may register by
notice pursuant to section 15(b)(11)(A) of the Exchange Act (15 U.S.C.
78o(b)(11)(A)) if it: (1) Is registered with the Commodity Futures
Trading Commission as a futures commission merchant or an introducing
broker, as those terms are defined in the Commodity Exchange Act (7
U.S.C. 1, et seq.); (2) is a member of the National Futures Association
or another national securities association registered under section
15A(k) of the Exchange Act (15 U.S.C. 78o-3(k)); and (3) is not
required to register as a broker or dealer in connection with
transactions in securities other than security futures products. The
rule also requires a broker or dealer registering by notice to do so by
filing Form BD-N in accordance with the instructions to the form. In
addition, the rule provides that if the information provided by filing
the form is or becomes inaccurate for any reason, the broker or dealer
shall promptly file an amendment on the form correcting such
information.
    The Commission staff estimates that the total annual reporting
burden associated with Rule 15b11-1 and Form BD-N is approximately two
hours, based on an average of two initial notice registrations per year
that each take approximately 30 minutes to complete, for one hour, plus
an average of three amendments per year that each take approximately
fifteen minutes to complete, for 0.75 hours, rounded up to one hour,
for a total of two hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (i) 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 email to:
<EMAIL_ADDRESS>and (ii) David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549, or by sending an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: February 18, 2020.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-03509 Filed 2-20-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 27, 2010 (Volume 75, Number 186)]
[Notices]
[Page 59281-59282]
[DOCID:fr27se10-111]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2010-0797]

Recognition of Foreign Certificates Under the International
Convention on Standards of Training, Certification and Watchkeeping for
Seafarers, 1978, as Amended, Regulation I/10

AGENCY: Coast Guard, DHS.

ACTION: Notice and request for comments.

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SUMMARY: Regulation I/10 of the International Convention on Standards
of Training, Certification and Watchkeeping for Seafarers, 1978, as
amended, (STCW) requires Parties to the Convention to establish
procedures to recognize STCW certificates issued by or under the
authority of another Party. In order to start this process, the Coast
Guard is developing a policy regarding the United States' recognition
of foreign certificates held by foreign maritime officers who may be
employed on some United States flag vessels. The Coast Guard is
soliciting comments from mariners, industry, and the public to assist
in development of this policy. The Coast Guard is particularly
interested in identifying which United States flag vessels employ
foreign citizens, the nationalities of these mariners, and the
countries that issue their STCW certificates.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before October 27,
2010 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-0797 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
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 about this
notice, call or e-mail Luke B. Harden, Mariner Credentialing Program
Policy Division (CG-5434), U.S. Coast Guard; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>If you have questions on viewing material
in the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to submit comments and related material on the
development of a policy regarding the recognition of foreign
International Convention on Standards of Training, Certification and
Watchkeeping for Seafarers, 1978, as amended (STCW) certificates held
by foreign mariners who may be employed on United States flag vessels.
All comments received will be posted, without change, to http://
www.regulations.gov and will include any personal information you have
provided.
    Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2010-0797) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online, or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Notices'' and insert ``USCG-2010-0797'' in the ``Keyword'' box. Click
``Search'' then click on the balloon shape in the ``Actions'' column.
If you submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8[frac12] by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period.
    Viewing the comments: To view the comments, go to http://
www.regulations.gov, click on the ``read comments'' box, which will
then become highlighted in blue. In the ``Keyword'' box insert ``USCG-
2010-0797'' and click ``Search.'' Click the ``Open Docket Folder'' in
the ``Actions'' column. If you do not have access to the Internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal

holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act system of records notice regarding our public dockets in
the January 17, 2008, issue of the Federal Register (73 FR 3316).

Background and Purpose

    STCW requirements: Regulation I/10 of the STCW requires Parties to
the Convention to establish procedures to recognize certificates issued
to maritime officers by or under the authority of another Party. STCW
also requires the flag state of a vessel to ensure that all officers
serving on board hold properly recognized and endorsed credentials.
    Citizenship waiver provisions within the United States Code: Title
46 of the United States Code (U.S.C.) allows the employment of foreign
citizens aboard certain United States flag vessels. Specifically, 46
U.S.C. 8103(b)(3) establishes authority to waive the requirement for
United States citizenship for:

    (A) An offshore supply vessel or other similarly engaged vessel
of less than 1,600 gross tons as measured under section 14502 of
this title, or an alternate tonnage measured under section 14302 of
this title as prescribed by the Secretary under section 14104 of
this title that operates from a foreign port;
    (B) A mobile offshore drilling unit or other vessel engaged in
support of exploration, exploitation, or production of offshore
mineral energy resources operating beyond the water above the outer
Continental Shelf (as that term is defined in section 2(a) of the
Outer Continental Shelf Lands Act (43 U.S.C. 1331(a)); and
    (C) Any other vessel if the Secretary determines, after an
investigation, that qualified seamen who are citizens of the United
States are not available.

    Need for the policy: Recognition of seafarer competence
certificates from other countries would ensure compliance with the STCW
Convention requirements, be in accordance with the citizenship waiver
requirements in 46 U.S.C. 8103(b)(3), and help ensure that United
States flagged vessels are not subject to detention in foreign ports
due to allegations of improperly credentialed seafarers. It would also
be done in anticipation of the regulatory changes that would be needed
to bring the United States into compliance with the STCW requirements.

The Proposed Policy

    Given this need, the Coast Guard is developing a policy to start
establishing a process for the United States' recognition of foreign
certificates held by foreign officers who may be employed on some
United States flag vessels.
    The Coast Guard is beginning to develop policy guidance for
arrangements between parties to STCW for recognition of certificates
under STCW Regulation I/10. The policy would provide guidance for Coast
Guard on how and when to recognize STCW certificates issued by other
countries. The policy would also provide a list of which countries'
certificates may be recognized and the process used to determine that
list.
    As part of this policy, we expect that once the United States is
satisfied that a certificate-issuing country complies with the STCW
Convention requirements concerning standards of competence, the issuing
and endorsement of certificates, and record keeping, both countries
could sign a written formal agreement establishing recognition of each
country's STCW certificates.
    The proposed policy could also offer guidance for mariners and/or
vessel operators/employers with regard to applying for and obtaining a
United States-issued endorsement of their foreign certificates.
    We welcome your comments on the above proposals. In particular, the
Coast Guard is interested in the following information:
    1. Which United States flag vessels employ foreign citizens?
    2. What are the nationalities of foreign citizens working United
States flag vessels?
    3. What countries issue STCW certificates for foreign citizens
working United States flag vessels?
    We will review and analyze all comments received in order to
develop the policy.

    Authority: We issue this notice of under the authority of 5
U.S.C. 552(a) and 46 U.S.C. 8103(b)(3).

    Dated: September 1, 2010.
Kevin S. Cook,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. 2010-24154 Filed 9-24-10; 8:45 am]
BILLING CODE 9110-04-P