[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Proposed Rules]
[Pages 11706-11711]
[FR Doc No: 2016-05032]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-1029]
RIN 1625-AA00

Safety Zones; Coast Guard Sector Ohio Valley Annual and Recurring
Safety Zones Update

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to amend and update its list of
recurring safety zone regulations that take place in the Coast Guard
Sector Ohio Valley area of responsibility (AOR). This notice informs
the public of regularly scheduled events that require additional safety
measures through establishing a safety zone. Through this notice the
current list of recurring safety zones is proposed to be updated with
revisions, additional events, and removal of events that no longer take
place in Sector Ohio Valley's AOR. When these safety zones are
enforced, vessel traffic is restricted from specified areas.
Additionally, this one proposed rulemaking project reduces
administrative costs involved in producing separate proposed rules for
each individual recurring safety zone and serves to provide notice of
the known recurring safety zones throughout the year.

DATES: Comments and related material must be received by the Coast
Guard on or before June 6, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-1029 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Petty Officer James Robinson, Sector Ohio Valley,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The legal basis for the rule is 33 U.S.C. 1231; 50 U.S.C. 191; 33
CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland
Security Delegation No. 0170.1, which collectively authorize the Coast
Guard to define regulatory safety zones.
    The Captain of the Port (COTP) Ohio Valley is proposing to
establish, amend, and update its current list of recurring safety zone
regulations.
    These safety zones are proposed to be added, amended, and updated
to the list of annually recurring safety zones under 33 CFR 165.801 in
Table no. 1 for annual safety zones in the COTP Ohio Valley zone. The
Coast Guard will address all comments accordingly, whether through
response, additional revision to the regulation, or otherwise.
Additionally, these recurring events are provided to the public through
local avenues and planned by the local communities.
    The current list of annual and recurring safety zones occurring in
Sector Ohio Valley's AOR is published under 33 CFR part 165.801. That
most recent list was created August 18, 2015 through the rulemaking 80
FR 49911, which finalized the interim rule

published April 22, 2014, 79 FR 22398, which received no adverse
comments. The August 18, 2015 rulemaking established 33 CFR 165.801
creating the current comprehensive list of recurring safety zones.
    The Coast Guard is amending and updating the safety zone
regulations under 33 CFR part 165 to include the most up to date list
of recurring safety zones for events held on or around navigable waters
within Sector Ohio Valley's AOR. These events include air shows,
fireworks displays, and other marine related events requiring a limited
access area restricting vessel traffic for safety purposes. The current
list under 33 CFR 165.801 requires amending to provide new information
on existing safety zones, updating to include new safety zones expected
to recur annually or biannually, and to remove safety zones that are no
longer required. Issuing individual regulations for each new safety
zone, amendment, or removal of an existing safety zone creates
unnecessary administrative costs and burdens. This single proposed
rulemaking will considerably reduce administrative overhead and
provides the public with notice through publication in the Federal
Register of the upcoming recurring safety zone regulations.
    The Coast Guard encourages the public to participate in this
proposed rulemaking through the comment process so that any necessary
changes can be identified and implemented in a timely and efficient
manner.

III. Discussion of the Rule

    33 CFR part 165 contains regulations establishing limited access
areas to restrict vessel traffic for the safety of persons and
property. Section 165.801 establishes recurring safety zones to
restrict vessel transit into and through specified areas to protect
spectators, mariners, and other persons and property from potential
hazards presented during certain events taking place in Sector Ohio
Valley's AOR. This section requires amendment from time to time to
properly reflect the recurring safety zone regulations in Sector Ohio
Valley's AOR. This proposed rule amends and updates Section 165.801
replacing the current Table 1 for Sector Ohio Valley.
    Additionally, this proposed rule adds 13 new recurring safety zones
and removes 6 safety zones.
    Thirteen new recurring safety zones are proposed to be added under
the new Table 1 of Sec.  165.801 for Sector Ohio Valley, as follows:

----------------------------------------------------------------------------------------------------------------
               Date                        Event/sponsor         Ohio Valley location        Regulated area
----------------------------------------------------------------------------------------------------------------
1 day--Last weekend in June or      Riverview Park              Louisville, KY.......  Ohio River, Mile 618.5-
 first weekend in July.              Independence Festival.                             619.5 (Kentucky).
1 day--First weekend in June......  Bellaire All-American Days  Bellaire, OH.........  Ohio River, Mile 93.5-
                                                                                94.5 (Ohio).
2 days--Second weekend of June....  Rice's Landing Riverfest..  Rices Landing, PA....  Monongahela River, Mile
                                                                                68.0-68.8
                                                                                (Pennsylvania).
1 day--Second full week of August.  PA FOB Fireworks Display..  Pittsburgh, PA.......  Allegheny River, Mile 0.8-
                                                                                1.0 (Pennsylvania).
1 day--Third week of August.......  Beaver River Regatta        Beaver, PA...........  Ohio River, Mile 25.2-
                                     Fireworks.                                         25.8 (Pennsylvania).
1 day--Fourth or Fifth of July....  City of Cape Girardeau      Cape Girardeau, MO...  Upper Mississippi River,
                                     July 4th Fireworks Show                            Mile 50.0-52.0
                                     on the River.                                      (Missouri).
Last Sunday in May................  Friends of Ironton........  Ironton, OH..........  Ohio River, Mile 326.7-
                                                                                327.7 (Ohio).
July 4th..........................  Greenup City..............  Greenup, KY..........  Ohio River, Mile 335.2-
                                                                                336.2 (Kentucky).
July 4th..........................  Middleport Community        Middleport, OH.......  Ohio River, Mile 251.5-
                                     Association.                                       252.5 (Ohio).
Second Saturday in September......  Ohio River Sternwheel       Marietta, OH.........  Ohio River, Mile 171.5-
                                     Festival Committee                                 172.5 (Ohio).
                                     fireworks.
July 4th..........................  People for the Point Party  South Point, OH......  Ohio River, Mile 317-318
                                     in the Park.                                       (Ohio).
1 day--Friday before Thanksgiving.  Kittanning Light Up Night   Kittanning, PA.......  Allegheny River, Mile
                                     Firework Display.                                  44.5-45.5
                                                                                (Pennsylvania).
First Saturday in October.........  West Virginia Motor Car     Charleston, WV.......  Kanawha River, Mile 58-59
                                     Festival.                                          (West Virginia).
----------------------------------------------------------------------------------------------------------------

    This proposed rule removes the following 6 safety zone regulations
from the existing Table 1 Part of Sec.  165.801 for Sector Ohio Valley,
as follows:

----------------------------------------------------------------------------------------------------------------
               Date                        Event/sponsor         Ohio Valley location        Regulated area
----------------------------------------------------------------------------------------------------------------
1 day--July 4th...................  Downtown Henderson Project/ Henderson, KY........  Ohio River, Mile 803.5-
                                     Henderson Independence                             804.5 (Kentucky).
                                     Bank Fireworks.
1 day--First or second weekend in   Zambelli Fireworks/         Louisville, KY.......  Ohio River, Miles 602.0-
 October.                            American Pyrotechnic                               606.0 (Kentucky).
                                     Association Annual
                                     Convention Fireworks
                                     Display.
1 day--July 4th...................  Lake Guntersville Chamber   Guntersville, AL.....  Tennessee River, Mile
                                     of Commerce/Lake                                   356.0-358.0 (Alabama).
                                     Guntersville 4th of July
                                     Celebration.
1 day--July 3rd or the weekend      City of Clarksville/        Clarksville, TN......  Cumberland River, Mile
 before July 3rd if the 3rd is on    Clarksville Independence                           103.0-105.0 (Tennessee).
 a weekday.                          Day Fireworks.
1 day--Labor Day weekend..........  Knoxville Tourism and       Knoxville, TN........  Tennessee River, Mile
                                     Sports Corporation/                                647.0-648.0 (Tennessee).
                                     Boomsday Festival.
1 day--Friday after Thanksgiving..  Chattanooga Presents/Grand  Chattanooga, TN......  Tennessee River, Mile
                                     Illumination.                                      463.0-469.0 (Tennessee).
----------------------------------------------------------------------------------------------------------------

    The effect of this proposed rule will be to restrict general
navigation in the safety zone during the event. Vessels intending to
transit the designated waterway through the safety zone will only be
allowed to transit the area when the COTP Ohio Valley, or designated
representative, has deemed it safe to do so or at the completion of the
event. The proposed annually recurring safety zones are necessary to
provide for the safety of life on navigable waters during the events.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    The Coast Guard expects the economic impact of this proposed rule
to be minimal, therefore a full regulatory evaluation is unnecessary.
This proposed rule establishes safety zones limiting access to certain
areas under 33 CFR part 165 within Sector Ohio Valley's AOR. The effect
of this proposed rulemaking will not be significant because these
safety zones are limited in scope and duration. Additionally, the
public is given advance notification through local forms of notice, the
Federal Register, and/or Notices of Enforcement and thus will be able
to plan operations around the safety zones in advance. Deviation from
the safety zones established through this proposed rulemaking may be
requested from the appropriate COTP and requests will be considered on
a case-by-case basis. Broadcast Notices to Mariners and Local Notices
to Mariners will also inform the community of these safety zones so
that they may plan accordingly for these short restrictions on transit.
Vessel traffic may request permission from the COTP Ohio Valley or a
designated representative to enter the restricted area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601 through
612, as amended, requires federal agencies to consider the potential
impact of regulations on small entities during rulemaking. The term
``small entities'' comprises small businesses, not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000. The Coast Guard certifies under 5
U.S.C. 605(b) that this proposed rule will not have a significant
economic impact on a substantial number of small entities.
    This proposed rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to transit the safety zone areas during periods of
enforcement. The safety zones will not have a significant economic
impact on a substantial number of small entities because they are
limited in scope and will be in effect for short periods of time.
Before the enforcement period, the Coast Guard COTP will issue maritime
advisories widely available to waterway users. Deviation from the
safety zones established through this proposed rulemaking may be
requested from the appropriate COTP and requests will be considered on
a case-by-case basis.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under E.O. 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. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule is
categorically excluded under

section 2.B.2, figure 2-1, paragraph (34(g) of the Instruction because
it involves establishment of safety zones. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the U.S. Coast Guard
proposes to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Amend Sec.  165.801 by revising table 1 to read as follows:

Sec.  165.801  Annual fireworks displays and other events in the Eighth
Coast Guard District requiring safety zones.

* * * * *

                 Table 1 of Sec.   165.801--Sector Ohio Valley Annual and Recurring Safety Zones
----------------------------------------------------------------------------------------------------------------
               Date                        Sponsor/name                Location               Safety zone
----------------------------------------------------------------------------------------------------------------
1. Multiple days--April through     Pittsburgh Pirates/         Pittsburgh, PA.......  Allegheny River, Mile 0.2-
 November.                           Pittsburgh Pirates                                 0.8 (Pennsylvania).
                                     Fireworks.
2. Multiple days--April through     Cincinnati Reds/Cincinnati  Cincinnati, OH.......  Ohio River, Mile 470.1-
 November.                           Reds Season Fireworks.                             470.4; extending 500 ft.
                                                                                from the State of Ohio
                                                                                shoreline (Ohio).
3. 2 days--Third Friday and         Thunder Over Louisville/    Louisville, KY.......  Ohio River, Mile 602.0-
 Saturday in April.                  Thunder Over Louisville.                           606.0 (Kentucky).
4. Last Sunday in May.............  Friends of Ironton........  Ironton, OH..........  Ohio River, Mile 326.7-
                                                                                327.7 (Ohio).
5. 3 days--Third weekend in April.  Henderson Tri-Fest/         Henderson, KY........  Ohio River, Mile 803.5-
                                     Henderson Breakfast Lions                          804.5 (Kentucky).
                                     Club.
6. 1 day--A Saturday in July......  Paducah Parks and           Paducah, KY..........  Ohio River, Mile 934.0-
                                     Recreation Department/                             936.0 (Kentucky).
                                     Cross River Swim.
7. 1 day--First weekend in June...  Bellaire All-American Days  Bellaire, OH.........  Ohio River, Mile 93.5-
                                                                                94.5 (Ohio).
8. 2 days--Second weekend of June.  Rice's Landing Riverfest..  Rices Landing, PA....  Monongahela River, Mile
                                                                                68.0-68.8
                                                                                (Pennsylvania).
9. 1 day--First Sunday in June....  West Virginia Symphony      Charleston, WV.......  Kanawha River, Mile 59.5-
                                     Orchestra/Symphony Sunday.                         60.5 (West Virginia).
10. 1 day--Saturday before 4th of   Riverfest Inc./Saint        St. Albans, WV.......  Kanawha River, Mile 46.3-
 July.                               Albans Riverfest.                                  47.3 (West Virginia).
11. 1 day--4th July...............  Greenup City..............  Greenup, KY..........  Ohio River, Mile 335.2-
                                                                                336.2 (Kentucky).
12. 1 day--4th July...............  Middleport Community        Middleport, OH.......  Ohio River, Mile 251.5-
                                     Association.                                       252.5 (Ohio).
13. 1 day--4th July...............  People for the Point Party  South Point, OH......  Ohio River, Mile 317-318
                                     in the Park.                                       (Ohio).
14. 1 day--Last weekend in June or  Riverview Park              Louisville, KY.......  Ohio River, Mile 618.5-
 first weekend in July.              Independence Festival.                             619.5 (Kentucky).
15. 1 day--Third or fourth week in  Upper Ohio Valley Italian   Wheeling, WV.........  Ohio River, Mile 90.0-
 July.                               Heritage Festival/Upper                            90.5 (West Virginia).
                                     Ohio Valley Italian
                                     Heritage Festival
                                     Fireworks.
16. 1 day--4th or 5th of July.....  City of Cape Girardeau      Cape Girardeau, MO...  Upper Mississippi River,
                                     July 4th Fireworks Show                            Mile 50.0-52.0.
                                     on the River.
17. 1 day--Third or fourth of July  Harrah's Casino/Metropolis  Metropolis, IL.......  Ohio River, Mile 942.0-
                                     Fireworks.                                         945.0 (Illinois).
18. 1 day--During the first week    Louisville Bats Baseball    Louisville, KY.......  Ohio River, Mile 603.0-
 of July.                            Club/Louisville Bats                               604.0 (Kentucky).
                                     Firework Show.
19. 1 day--July 4th...............  Waterfront Independence     Louisville, KY.......  Ohio River, Mile 603.0-
                                     Festival/Louisville                                604.0 (Kentucky).
                                     Orchestra Waterfront 4th.
20. 1 day--During the first week    Celebration of the          Owensboro, KY........  Ohio River, Mile 755.0-
 of July.                            American Spirit Fireworks/                         759.0 (Kentucky).
                                     All American 4th of July.

21. 1 day--During the first week    Riverfront Independence     New Albany, IN.......  Ohio River, Mile 602.0-
 of July.                            Festival Fireworks.                                603.5 (Indiana).
22. 1 day--July 4th...............  Shoals Radio Group/Spirit   Florence, AL.........  Tennessee River, Mile
                                     of Freedom Fireworks.                              255.0-257.0 (Alabama).
23. 1 day--Saturday before July     Town of Cumberland City/    Cumberland City, TN..  Cumberland River, Mile
 4th.                                Lighting up the                                    103.0-105.0 (Tennessee).
                                     Cumberlands Fireworks.
24. 1 day--July 4th...............  Knoxville office of         Knoxville, TN........  Tennessee River, Mile
                                     Special Events/Knoxville                           647.0-648.0 (Tennessee).
                                     July 4th Fireworks.
25. 1 day--July 4th...............  NCVC/Music City July 4th..  Nashville, TN........  Cumberland River, Mile
                                                                                190.0-192.0 (Tennessee).
26. 1 day--Saturday before July     Grand Harbor Marina/Grand   Counce, TN...........  Tennessee-Tombigbee
 4th, or Saturday after July 4th.    Harbor Marina July 4th                             Waterway, Mile 450.0-
                                     Celebration.                                       450.5 (Tennessee).
27. 1 day--Second Saturday in July  City of Bellevue, KY/       Bellevue, KY.........  Ohio River, Mile 468.2-
                                     Bellevue Beach Park                                469.2 (Kentucky and
                                     Concert Fireworks.                                 Ohio).
28. 1 day--Sunday before Labor Day  Cincinnati Bell, WEBN, and  Cincinnati, OH.......  Ohio River, Mile 469.2-
                                     Proctor and Gamble/                                470.5 (Kentucky and
                                     Riverfest.                                         Ohio).
29. 1 day--July 4th...............  Summer Motions Inc./Summer  Ashland, KY..........  Ohio River, Mile 322.1-
                                     Motion.                                            323.1 (Kentucky).
30. 1 day--Last weekend in June or  City of Point Pleasant/     Point Pleasant, WV...  Ohio River, Mile 265.2-
 First weekend in July.              Point Pleasant Sternwheel                          266.2 (West Virginia).
                                     Fireworks.
31. 1 day--July 3rd or 4th........  City of Charleston/City of  Charleston, WV.......  Kanawha River, Mile 58.1-
                                     Charleston Independence                            59.1 (West Virginia).
                                     Day Celebration.
32. 1 day--July 4th...............  Civic Forum/Civic Forum     Portsmouth, OH.......  Ohio River, Mile 355.5-
                                     4th of July Celebration.                           356.5 (Ohio).
33. 1 day--Second Saturday in       Guyasuta Days Festival/     Pittsburgh, PA.......  Allegheny River, Mile
 August.                             Borough of Sharpsburg.                             005.5-006.0
                                                                                (Pennsylvania).
34. 1 day--Third week in October..  Pittsburgh Foundation/Bob   Pittsburgh, PA.......  Ohio River, Mile 0.0-0.5
                                     O'Connor Cookie Cruise.                            (Pennsylvania).
35. 1 day--Second full week of      PA FOB Fireworks Display..  Pittsburgh, PA.......  Allegheny River, Mile 0.8-
 August.                                                                                1.0 (Pennsylvania).
36. 1 day--Third week of August...  Beaver River Regatta        Beaver, PA...........  Ohio River, Mile 25.2-
                                     Fireworks.                                         25.8 (Pennsylvania).
37. 1 day--December 31............  Pittsburgh Cultural Trust/  Pittsburgh, PA.......  Allegheny River Mile, 0.5-
                                     Highmark First Night                               1.0 (Pennsylvania).
                                     Pittsburgh.
38. 1 day--Friday before            Pittsburgh Downtown         Pittsburgh, PA.......  Allegheny River, Mile 0.0-
 Thanksgiving.                       Partnership/Light Up                               1.0 (Pennsylvania).
                                     Night.
39. Multiple days--April through    Pittsburgh Riverhounds/     Pittsburgh, PA.......  Monongahela River, Mile
 November.                           Riverhounds Fireworks.                             0.22-0.77.
                                                                                (Pennsylvania).
40. 3 days--Second or third         Hadi Shrine/Evansville      Evansville, IN.......  Ohio River, Miles 791.0-
 weekend in June.                    Freedom Festival Air Show.                         795.0 (Indiana).
41. 1 day--Second or third          Friends of the Festival,    Chattanooga, TN......  Tennessee River, Mile
 Saturday in June, the last day of   Inc./Riverbend Festival                            463.5-464.5 (Tennessee).
 the Riverbend Festival.             Fireworks.
42. 2 days--Second Friday and       City of Newport, KY/        Newport, KY..........  Ohio River, Miles 469.6-
 Saturday in June.                   Italianfest.                                       470.0 (Kentucky and
                                                                                Ohio).
43. 1 day--Last Saturday in June..  City of Aurora/Aurora       Aurora, IN...........  Ohio River Mile, 496.7;
                                     Firecracker Festival.                              1400 ft. radius from the
                                                                                Consolidated Grain Dock
                                                                                located along the State
                                                                                of Indiana shoreline at
                                                                                (Indiana and Kentucky).
44. 1 day--second weekend in June.  City of St. Albans/St.      St. Albans, WV.......  Kanawha River, Mile 46.3-
                                     Albans Town Fair.                                  47.3 (West Virginia).
45. 1 day--Saturday before July     PUSH Beaver County/Beaver   Beaver, PA...........  Ohio River, Mile 24.0-
 4th.                                County Boom.                                       25.6 (Pennsylvania).
46. 1 day--4th of July (Rain date-- Monongahela Area Chamber    Monongahela, PA......  Monongahela River, Mile
 July 5th).                          of Commerce/Monongahela                            032.0-033.0
                                     4th of July Celebration.                           (Pennsylvania).
47. 1 day--Saturday Third or        Oakmont Yacht Club/Oakmont  Oakmont, PA..........  Allegheny River, Mile
 Fourth full week of July (Rain      Yacht Club Fireworks.                              12.0-12.5
 date--following Sunday).                                                               (Pennsylvania).
48. 1 day--Week of July 4th.......  Three Rivers Regatta        Pittsburgh, PA.......  Ohio River, Mile 0.0-0.5,
                                     Fireworks/EQT 4th of July                          Allegheny River, Mile
                                     Celebration.                                       0.0-0.5, and Monongahela
                                                                                River, Mile 0.0-0.5
                                                                                (Pennsylvania).
49. 1 day--3rd or 4th of July.....  City of Paducah, KY.......  Paducah, KY..........  Ohio River, Mile 934.0-
                                                                                936.0; Tennessee River,
                                                                                mile 0.0--1.0
                                                                                (Kentucky).
50. 1 day--3rd or 4th of July.....  City of Hickman, KY.......  Hickman, KY..........  Lower Mississippi River,
                                                                                Mile 921.0-923.0
                                                                                (Kentucky).
51. 1 day--During the first week    Evansville Freedom          Evansville, IN.......  Ohio River, Miles 791.0-
 of July.                            Celebration.                                       795.0 (Indiana).
52. 3 days--One of the first two    Madison Regatta, Inc./      Madison, IN..........  Ohio River, Miles 555.0-
 weekends in July.                   Madison Regatta.                                   560.0 (Indiana).

53. 1 day--July 4th...............  Cities of Cincinnati, OH    Newport, KY..........  Ohio River, Miles 469.6-
                                     and Newport, KY/July 4th                           470.2 (Kentucky and
                                     Fireworks.                                         Ohio).
54. 2 days--second weekend in July  Marietta Riverfront Roar/   Marietta, OH.........  Ohio River, Mile 171.6-
                                     Marietta Riverfront Roar.                          172.6 (Ohio).
55. 1 day--1st weekend in July....  Gallia County Chamber of    Gallipolis, OH.......  Ohio River, Mile 269.5-
                                     Commerce/Gallipolis River                          270.5 (Ohio).
                                     Recreation Festival.
56. 1 day--July 4th...............  Kindred Communications/     Huntington, WV.......  Ohio River, Mile 307.8-
                                     Dawg Dazzle.                                       308.8 (West Virginia).
57. 1 day--Last weekend in August.  Swiss Wine Festival/Swiss   Ghent, KY............  Ohio River, Mile 537
                                     Wine Festival Fireworks                            (Kentucky).
                                     Show.
58. 1 day--Saturday of Labor Day    University of Pittsburgh    Pittsburgh, PA.......  Allegheny River, Mile 0.0-
 weekend.                            Athletic Department/                               0.25 (Pennsylvania).
                                     University of Pittsburgh
                                     Fireworks.
59. Sunday, Monday, or Thursday     Pittsburgh Steelers         Pittsburgh, PA.......  Ohio River, Mile 0.3-
 from September through January.     Fireworks.                                         Allegheny River, Mile
                                                                                0.2 (Pennsylvania).
60. 3 days--Third weekend in        Wheeling Heritage Port      Wheeling, WV.........  Ohio River, Mile 90.2-
 September.                          Sternwheel Festival                                90.7 (West Virginia).
                                     Foundation/Wheeling
                                     Heritage Port Sternwheel
                                     Festival.
61. 1 day--Second Saturday in       Ohio River Sternwheel       Marietta, OH.........  Ohio River, Mile 171.5-
 September.                          Festival Committee                                 172.5 (Ohio).
                                     fireworks.
62. 1 day--Second weekend of        Leukemia and Lymphoma       Nashville, TN........  Cumberland River, Mile
 October.                            Society/Light the Night                            190.0-192.0 (Tennessee).
                                     Walk Fireworks.
63. 1 day--First Saturday in        West Virginia Motor Car     Charleston, WV.......  Kanawha River, Mile 58-59
 October.                            Festival.                                          (West Virginia).
64. 1 day--Friday before            Kittanning Light Up Night   Kittanning, PA.......  Allegheny River, Mile
 Thanksgiving.                       Firework Display.                                  44.5-45.5
                                                                                (Pennsylvania).
65. 1 day--First week in October..  Leukemia & Lymphoma         Pittsburgh, PA.......  Ohio River, Mile 0.0-0.4
                                     Society/Light the Night.                           (Pennsylvania).
66. 1 day--Friday before            Duquesne Light/Santa        Pittsburgh, PA.......  Monongahela River, Mile
 Thanksgiving.                       Spectacular.                                       0.00-0.22, Allegheny
                                                                                River, Mile 0.00-0.25,
                                                                                and Ohio River, Mile 0.0-
                                                                                0.3 (Pennsylvania).
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: January 5, 2016.
R.V. Timme,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2016-05032 Filed 3-4-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75477-75481]
[FR Doc No: 2010-30385]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0266]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Clinical
Efficacy Information in Professional Labeling and Direct-to-Consumer
Print Advertisements for Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
3, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-new and
title ``Study of Clinical Efficacy Information in Professional Labeling
and Direct-to-Consumer (DTC) Print Advertisements for Prescription
Drugs.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Study of Clinical Efficacy Information in
Professional Labeling and Direct-to-Consumer (DTC)
    Print Advertisements for Prescription Drug--(OMB Control Number
0910-New)
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 903(b)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    FDA regulations require that an advertisement that makes claims
about a prescription drug include a ``fair balance'' of information
about the benefits and risks of the advertised product, in terms of
both content and presentation (21 CFR 202.1(e)(5)(ii)). In past
research FDA has focused primarily on the risk component of the risk-
benefit ratio. In the interest of thoroughly exploring the issue of
fair balance, however, the presentation of effectiveness, or benefit,
information is equally important.
    The FD&C Act requires that manufacturers, packers, and distributors
(sponsors) who advertise prescription human and animal drugs, including
biological products for humans, disclose in advertisements certain
information about the advertised product's uses and risks.\1\ By its
nature, the presentation of this risk information is likely to evoke
active trade-offs by consumers, i.e., comparisons with the perceived
risks of not taking treatment, and comparisons with the perceived
benefits of taking a treatment.\2\ Since FDA has an interest in
fostering safe and proper use of prescription drugs, an activity that
engages both risks and benefits, an in-depth understanding of
consumers' processing of this information is central to this regulatory
task.
---------------------------------------------------------------------------

    \1\ For prescription drugs and biologics, the FD&C Act requires
advertisements to contain ``information in brief summary relating to
side effects, contraindications, and effectiveness'' (21 U.S.C.
352(n)).
    \2\ See Schwartz, L., S. Woloshin, W. Black, et al., ``The Role
of Numeracy in Understanding the Benefit of Screening Mammography,''
Annals of Internal Medicine, 127(11), 966-72, 1997.
---------------------------------------------------------------------------

    Research and guidance to sponsors on how to present benefit and
efficacy information in prescription drug advertisements is limited.
For example, ``benefit claims,'' broadly defined, appearing in
advertisements are often presented in general language that does not
inform patients of the likelihood of efficacy and are often simply
variants of an ``intended use'' statement. In a content analysis of DTC
advertising,\3\ the researchers classified the ``promotional
techniques'' used in the advertisements. Emotional appeals were
observed in 67 percent of the ads while vague and qualitative benefit
terminology was found in 87 percent of the ads. Only 9 percent
contained data. For risk information, however, half the advertisements
used data to describe side-effects, typically with lists of side-
effects that generally occurred infrequently.
---------------------------------------------------------------------------

    \3\ Woloshin, S. and L. Schwartz, ``Direct to Consumer
Advertisements for Prescription Drugs: What Are Americans Being
Told,'' Lancet, 358, 1141-46, 2001.
---------------------------------------------------------------------------

    FDA regulations require that prescription drug advertisements that
make (promotional) claims about a product also include risk information
in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. This balance applies to
both the front (aka ``display'') page of an advertisement, as well as
the brief summary page. However, beyond the ``balance'' requirement
limited guidance and research exists to direct or encourage sponsors to
present benefit claims that are informative, specific, and reflect
clinical effectiveness data.
    The purpose of this project is to: (1) Understand how physicians
process clinical efficacy information and how

they interpret approved product label information,\4\ (2) determine
physician preferences for alternative presentations of clinical
efficacy information in DTC advertising, and (3) examine how different
presentations of clinical efficacy information in DTC advertising
affect consumers' perceptions of efficacy and safety. Specifically, we
are interested in how physicians and consumers make risk/benefit
assessments and particularly, how consumers make such judgments in
response to variations in the efficacy presentations in the ``display''
(first) page of a DTC print ad. A particular concern is whether certain
presentations cause consumers to form skewed perceptions or unfounded
risk/benefit tradeoffs. Therefore, we will investigate to what extent
consumers, when provided with efficacy information, form perceptions
that correspond with clinically-based physicians' assessments of the
benefits, risks, and benefit/risk tradeoffs of the same drugs. These
studies will inform FDA's thinking regarding how manufacturers may
provide useful and non-misleading efficacy information in DTC print
advertisements.
---------------------------------------------------------------------------

    \4\ As part of this effort, a qualitative mental models
procedure was completed that helped us determine how physicians
think about the efficacy of potential pharmaceutical options (OMB
control no. 0910-0649).
---------------------------------------------------------------------------

Design Overview

    This study will be conducted in two concurrent, independent parts.
The first part will involve 2,500 consumers in an experimental
examination of variations of the display page of print DTC ads for two
fictitious drugs, closely approximating existing drugs for overactive
bladder (OAB) and benign prostatic hyperplasia (BPH). In the second
part, 600 general practitioners will review and evaluate a fictitious
``approved'' label for the same conditions. This design will allow us
to compare consumers' perceptions of efficacy with a more objective
measure of the true efficacy of the drug as measured by physician
perceptions of clinical efficacy from labeling.
    Consumer experiment. In this part of the study, women who have been
diagnosed with or are at risk for OAB (self-designated based on
relevant symptoms) will be recruited and will view one version of a DTC
ad for a drug to treat OAB. Men who have been diagnosed with or are at
risk for BPH (self-designated based on relevant symptoms) will be
recruited and will view one version of a DTC ad for a drug to treat
BPH. Although the two conditions are somewhat specific to gender (men
can suffer from OAB but it is much more prevalent in women), they share
many of the same symptoms and characteristics. These medical conditions
afford us the ability to maintain various realistic manipulations of
placebo level and type of claim, as explained below. The graphical
elements and construction of the two ads will be comparable yet still
realistic.
    Consumers will be randomly assigned to see 1 of 12 DTC print ads
within their respective medical condition and will answer questions
about the effectiveness and safety of the fictitious drug advertised in
them. These twelve experimental conditions will be created by examining
three independent variables in the following manner: Type of claim (2
levels: Treatment, prevention), placebo rate (3 levels: High, low,
none), and framing (2 levels: Single, mixed). Please note that the
numbers describing efficacy seen in the following table are for
illustration only. Actual numbers used will be determined by
pretesting.

BILLING CODE 4160-01-P

[GRAPHIC] [TIFF OMITTED] TN03DE10.010

BILLING CODE 4160-01-C
    We will investigate variations of numerical presentation in two
different types of claims: treatment and prevention. Treatment claims
usually involve symptoms that may be alleviated by taking a given
prescription drug. This type of claim is directly observable and
somewhat testable by patients. If bothersome symptoms do not go away, a
patient can return to the healthcare provider with this information and
pursue additional options for treatment. In general, drugs that treat
symptoms typically show substantial percentages of people who
experience relief.
    Prevention claims are important but due to their long-term nature,
potentially harder to communicate. A drug that prevents a negative
future event may not alleviate any symptoms

at all. Patients may feel no benefit from the drug and must trust their
healthcare provider and the data, as much as they can process it, that
the drug is providing a positive benefit for them. The nature of these
claims is such that the event being prevented is relatively rare, and
thus the numbers used to describe them are often very small. For
example, a cholesterol drug that reduces the risk of heart attack from
3 out of 100 to 2 out of 100 may not seem objectively large, but has
enormous consequences for millions of people and the healthcare system
in general. We chose to test this type of claim to determine whether
consumers are sensitive to the magnitude of the benefit in these
clinically meaningful but objectively small and usually asymptomatic
outcomes. While we will examine the current issues in both treatment
and prevention claims, we do not intend to make comparisons between the
two.
    The second variable of interest is communication of a placebo rate.
Three levels will be examined. In addition to testing a control
condition with no placebo information, we will utilize a high and low
placebo rate to better understand if and how consumers use placebo
information. We see three possibilities: (1) People use placebo numbers
correctly, such that the low placebo group demonstrates higher
perceived efficacy than the high placebo group; (2) people use the
placebo numbers as a peripheral cue to mean ``science'' so there are no
differences between high and low placebo groups on perceived efficacy
but both are higher than the no placebo group; and (3) people do not
find the numbers meaningful or cannot process them, so the high and low
groups do not differ from one another and they do not differ from the
no placebo group. In an attempt to make our claims as realistic as
possible, we will maintain fairly low rates of prevention in the
prevention conditions. For this reason, in addition to the 12 cells in
the table previously illustrated in this document, we will also have an
additional control cell in which the effectiveness rates are quite
high--higher than could reasonably be expected but high enough to be
objectively noticeable (e.g., risk of bladder cancer on Drug X, 4/100;
risk of bladder cancer on placebo, 15/100). This additional condition
will provide confidence that our research manipulations are operating
as we expect.
    Finally, we will examine the addition of mixed framing to the
traditional use of a single positive frame in a DTC ad. Mixed framing
provides the number of people who benefited and the number of people
who did not benefit, whereas positive framing provides only the number
of people who benefited. Only a few studies have actually measured this
mixed approach \5\ although risk communication guides recommend the use
of mixed framing to create more accurate perceptions.\6\ Although a
completely balanced design would also include a negative framing
condition (which would provide only the number of people who did not
benefit), we feel it is unrealistic to create an ad that would suggest,
for example, that ``Drug X did not work for 70 percent of people in
clinical trials,'' so we have chosen not to include negative framing in
our investigation.
---------------------------------------------------------------------------

    \5\ For a literature review, see Moxey, A., D. O'Connell, P.
McGettigan, et al., ``Describing Treatment Effects to Patients: How
They Are Expressed Makes a Difference,'' Journal of General Internal
Medicine, 18, 948-959, 2003.
    \6\ Fagerlin, A., P.A. Ubel, D.M. Smith, et al., ``Making
Numbers Matter: Present and Future Research in Risk Communication,''
American Journal of Health Behavior, 31, S47-S56, 2007; Schwartz,
L.M., S. Woloshin, H.G. Welch, ``Risk Communication in Clinical
Practice: Putting Cancer in Context,'' Monograph of the National
Cancer Institute, 25, 124-133, 1999.
---------------------------------------------------------------------------

    In this part of the project, we are most interested in consumers'
perceived efficacy and safety, which we can then compare with ratings
physicians will provide based on the prescribing information, described
in the next section. We will also ask consumers questions to measure
their accuracy with regard to claims, their recall of the information
in the ad, and demographic questions that may influence their
responses, such as knowledge about their medical condition and their
level of numeracy.
    Physician Study. Six hundred general practitioners \7\ will
participate in an Internet survey lasting no longer than 20 minutes.
They will complete two tasks during this time. In the first task, they
will evaluate a prescription drug label (also known as the prescribing
information, written for healthcare practitioners) for one of the two
fictitious drugs described in the consumer study below. To provide a
match for the variations of information in the DTC ads the consumers
will observe, physicians will be randomly assigned to see prescribing
information that varies in terms of claim type, placebo rates in
clinical trials, and the medical condition the drug treats (OAB or
BPH).
---------------------------------------------------------------------------

    \7\ Including internists, general practitioners, and family
practitioners.
---------------------------------------------------------------------------

    As part of this task, we will obtain timing and sequence
information on which sections of the label physicians examine. This
will enable us to have a deeper understanding of physicians' processing
of the prescribing information. We are not aware of existing literature
on this topic. Additionally, physicians will answer questions about the
efficacy and safety of the drug and quantitative questions about the
benefit shown in the clinical studies (as described in the label).
These questions have been designed such that they can be reasonably
compared with the responses of consumers who will answer the same
questions after viewing a corresponding DTC ad.
    In the second task, physicians will see four versions of a print
DTC ad for a fictitious product for high cholesterol and will rank the
ads in order of how representative of the clinical data as the
physicians know it the ads are and how useful they believe the ads
would be for their patients.\8\ The four versions will be selected to
mirror the versions of the OAB/BPH drug that consumers will see in the
consumer experiment (i.e., low placebo, frame).
---------------------------------------------------------------------------

    \8\ To reduce burden, the physician sample will be split in this
task, so that half of the physicians see the four ad versions with
treatment claims and the other half see the four ad versions with
prevention claims. Type of claim is described in greater detail in
the consumer experiment section.
---------------------------------------------------------------------------

    Thus, this research will provide us with a rich data set in order
to address several questions: (1) How physicians process clinical
efficacy information and how they use approved product label
information, (2) how physicians' interpretations of clinical efficacy
information relate to their preferences for alternative DTC ad
presentations, and (3) which variations of information in DTC ads bring
consumers closer to or farther away from the conclusions of the
physicians regarding the same drugs.
    FDA estimates the burden of this collection of information as
follows:
    The total respondent sample for this data collection is 3,400. We
estimate the response burden to be 20 minutes in the first part and 15
minutes in the second part, for a burden of 906 hours.
    In the Federal Register of June 16, 2010 (75 FR 34142), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the paperwork
burden.
    FDA estimates the burden of this collection of information as
follows:

                              Table 1--Total Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
Physician survey--pretest.......             100               1             100             .33              33
Physician survey--main study....             600               1             600             .33             198
Consumer experiment--pretest....             200               1             200             .25              50
Consumer experiment--main study.           2,500               1           2,500             .25             625
                                 -------------------------------------------------------------------------------
    Total.......................                                                                             906
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30385 Filed 12-2-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Pages 3803-3805]
[FR Doc No: 2016-01172]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-5105]

Postmarket Management of Cybersecurity in Medical Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Postmarket Management of
Cybersecurity in Medical Devices.'' This draft guidance informs
industry and FDA staff of the Agency's recommendations for identifying,
addressing, and monitoring cybersecurity vulnerabilities and exploits
for postmarket management of medical devices. This draft guidance is
neither final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-5105 for ``Postmarket Management of Cybersecurity in Medical
Devices.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this

information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002 or the Office of Communication, Outreach, and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002, 301-
796-6937; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance proposes to inform industry and FDA staff of
the Agency's recommendations as it relates to monitoring, identifying,
and addressing cybersecurity vulnerabilities and exploits as part of
manufacturers' postmarket management of medical devices. A growing
number of medical devices are designed to be networked to facilitate
patient care. Networked medical devices, like other networked computer
systems, incorporate software that may be vulnerable to cybersecurity
threats. The exploitation of vulnerabilities may represent a risk to
the safety and effectiveness of medical devices and typically requires
continual maintenance throughout the product life cycle to assure an
adequate degree of protection against such exploits. Proactively
addressing cybersecurity risks in medical devices reduces the patient
safety impact and the overall risk to public health.
    For the majority of cases, actions taken by manufacturers to
address cybersecurity vulnerabilities and exploits are considered
``cybersecurity routine updates and patches,'' for which the FDA does
not require advance notification or reporting under 21 CFR part 806.
For a small subset of cybersecurity vulnerabilities and exploits that
may compromise the essential clinical performance of a device and
present a reasonable probability of serious adverse health consequences
or death, the FDA would require medical device manufacturers to notify
the Agency.
    In February 2013, the President issued Executive Order 13636 (E.O.
13636), ``Improving Critical Infrastructure Cybersecurity,'' which
recognized that resilient infrastructure is essential to preserving
national security, economic stability, and public health and safety in
the United States. Furthermore, Presidential Policy Directive-21 (PPD-
21) tasks Federal Government entities to strengthen the security and
resilience of critical infrastructure against physical and cyber
threats such that these efforts reduce vulnerabilities, minimize
consequences, and identify and disrupt threats.
    In addition, Executive Order 13691, released in February 2015,
encourages the development of Information Sharing Analysis
Organizations (ISAOs) to serve as focal points for cybersecurity
information sharing and collaboration within the private sector and
between the private sector and the government.
    FDA believes that, in alignment with E.O. 13636 and PPD-21,
stakeholders should collaborate to leverage available resources and
tools to establish a common framework among the information technology
community, healthcare delivery organizations (HDOs), clinical user
community, and medical device community. These collaborations can lead
to the consistent assessment and mitigation of cybersecurity threats,
and their impact on medical device safety and effectiveness.
    FDA plans to hold a public workshop entitled ``Moving Forward:
Collaborative Approaches to Medical Device Cybersecurity'' on January
20-21, 2016 (80 FR 76022, December 7, 2015). FDA, in collaboration with
the National Health Information Sharing Analysis Center, the Department
of Health and Human Services, and the Department of Homeland Security,
seek to bring together diverse stakeholders to discuss complex
challenges in medical device cybersecurity that impact the medical
device ecosystem. The purpose of this workshop is to highlight past
collaborative efforts; increase awareness of existing maturity models
(i.e., frameworks leveraged for benchmarking an organization's
processes) which are used to evaluate cybersecurity status, standards,
and tools in development; and to engage the multi-stakeholder community
in focused discussions on unresolved gaps and challenges that have
hampered progress in advancing medical device cybersecurity.
    In the last few years, Healthcare and Public Health Critical
Infrastructure Sector stakeholders have been engaged in many
collaborative activities that seek to strengthen medical device
cybersecurity and, therefore, enhance patient safety. FDA has
contributed to these efforts through guidance, multistakeholder
engagement, outreach, and by hosting a 2014 public workshop on
cybersecurity entitled ``Collaborative Approaches for Medical Device
and Healthcare Cybersecurity'' (79 FR 56814, September 23, 2014). The
2016 public workshop will build upon previous work by featuring some of
the collaborative efforts that address medical device cybersecurity
through education and training, information sharing, standards, risk
assessment, and tools development.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on postmarket
management of cybersecurity in medical devices. It neither creates nor
confers any rights for or on any person and is not binding on FDA or
the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of
``Postmarket Management of Cybersecurity in Medical Devices'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1400044 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collections of information in 21 CFR part 803 (medical device
reporting) have been approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 806 (reports of corrections
and removals) have been approved under OMB control number 0910-0359;
the collections of information in 21 CFR part 810 (medical device
recall authority) have been approved under OMB control number 0910-
0432; the collections of information in 21 CFR part 814 (premarket
approval) have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 820 (quality system
regulations) have been approved under OMB control number 0910-0073; and
the collections of information in 21 CFR part 822 (postmarket
surveillance of medical devices) have been approved under OMB control
number 0910-0449.

V. Other Issues for Consideration

    The Agency invites comments on the ``Postmarket Management of
Cybersecurity in Medical Devices'' draft guidance, in general, and on
the following questions, in particular:
     What factors contribute to a manufacturer's decision
whether or not to participate in an ISAO?
     In the draft guidance, the FDA is proposing its intention
to not enforce certain regulatory requirements for manufacturer's that
are ``participating members '' of an ISAO. Should FDA define what it
means to be a ``participating member'' of an ISAO and if so, how should
such participation be verified?
     What are the characteristics (participation, expertise,
policies, and practices) of an ISAO that would make it qualified to
participate in the sharing and analysis of medical device cybersecurity
vulnerabilities? What are the benefits and disadvantages of FDA
``recognizing'' specific ISAOs as possessing specialized expertise
relevant to sharing and analysis of medical device vulnerabilities and
what should such recognition entail?
     When cybersecurity vulnerability information is not
reported to FDA, what information should be reported to the ISAO, and
when?
     How should the FDA interact with ISAOs, manufacturers,
HDOs, security researchers and other stakeholders to maximize the
sharing of information concerning cybersecurity threats while
maintaining confidentiality and protecting commercial confidential
information?

    Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01172 Filed 1-21-16; 8:45 am]
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