[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52442-52443]
[FR Doc No: 2018-22611]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC18-21-000]

Commission Information Collection Activities (FERC-725G); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-725G (Reliability Standards for the Bulk
Power System: PRC Reliability Standards, OMB Control No. 1902-0252).
    As part of this extension request, FERC will transfer the
information collection requirements and burden of the FERC-725G1 (OMB
Control No. 1902-0284) and FERC-725G4 (OMB Control No. 1902-0282) into
FERC-725G. FERC-725G1 and FERC-725G4 information collections will
eventually be discontinued.

DATES: Comments on the collection of information are due December 17,
2018.

ADDRESSES: You may submit comments (identified by Docket No. IC18-21-
000) by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725G (Reliability Standards for the Bulk Power System:
PRC Reliability Standards).\1\
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    \1\ The current information collection requirements of the FERC-
725G1 (OMB Control No. 1902-0284) and FERC-725G4 (OMB Control No.
1902-0282) are being transferred into the FERC-725G.
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    OMB Control No.: 1902-0252.
    Type of Request: Request a three-year extension of the FERC-725G
information collection requirements (including the information
collection requirements transferred from the FERC-725G1 and FERC-725G4)
with no changes to the current reporting requirements.
    Abstract: The information collected by the FERC-725G is required to
implement the statutory provisions of section 215 of the Federal Power
Act (FPA).\2\ Section 215 of the FPA buttresses the Commission's
efforts to strengthen the reliability of the interstate bulk power
grid.
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    \2\ 16 U.S.C. 824o.
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    The FERC-725G information collection currently contains the
reporting and recordkeeping requirements for the following Reliability
Standards:

 PRC-002-2 (Disturbance Monitoring and Reporting Requirements)
 PRC-006-2 (Automatic Underfrequency Load Shedding)
 PRC-012-2 (Remedial Action Schemes)
 PRC-019-1 (Coordination of Generating Unit or Plant
Capabilities, Voltage Regulating Controls, and Protection)
 PRC-023-4 (Transmission Relay Loadability)
 PRC-024-1 (Generator Frequency and Voltage Protective Relay
Settings)
 PRC-025-1 (Generator Relay Loadability)
 PRC-026-1 (Relay Performance During Stable Power Swings)
 PRC-027-1 (Coordination of Protection Systems for Performance
During Faults)

    Additionally, the information collection requirements of the
following Reliability Standards will be incorporated into FERC-725G:

 PRC-004-5(i) \3\ (Protection System Misoperation
Identification and Correction) and
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    \3\ This standard is currently contained in the FERC-725G1
information collection. FERC-725G1 will eventually be discontinued.
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 PRC-010-2 \4\ (Undervoltage Load Shedding)
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    \4\ This standard is currently contained in the FERC-725G4
information collection. FERC-725G4 will eventually be discontinued.

    Each of these Reliability Standards has three components that
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impose burden upon affected industry:

 Requirements (e.g., denoted in each Reliability Standard as
R1, R2. . .)
 Measures (e.g., denoted in each Reliability Standard as M1,
M2. . .)
 Evidence Retention

    These three components can be reviewed for the Reliability
Standards in NERC petitions in FERC's eLibrary system (http://www.ferc.gov/docs-filing/elibrary.asp) or on NERC's own website
(www.nerc.com).
    Type of Respondents: Transmission owners, generator owners,
distribution providers, planning coordinators and transmission
planners.
    Estimate of Annual Burden: \5\ The Commission estimates the annual
public reporting burden and cost \6\ for the information collection as:
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    \5\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.
    \6\ The hourly cost (for salary plus benefits) uses the figures
from the Bureau of Labor Statistics, May 2017. Unless otherwise
specified, this figure includes salary (https://www.bls.gov/oes/current/naics2_22.htm) and benefits http://www.bls.gov/news.release/ecec.nr0.htm) for an Electrical Engineer (Occupation Code: 17-2071,
$66.90/hour) and an Information and Record Clerk (Occupation Code:
43-4199, $39.68/hour). All of the reporting requirements use the
electrical engineer rate for cost calculation. Similarly, all of the
record-keeping requirements use the information and record clerk
rate for cost calculation.

                                          FERC-725G--Mandatory Reliability Standards: PRC Reliability Standards
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                                                             Annual number                  Average burden & cost   Total annual burden      Cost per
       Reliability standards         Number of respondents   of responses    Total number     ($) (rounded) per     hours & total annual    respondent
                                              \7\           per respondent   of responses          response          cost ($) (rounded)    (rounded) ($)
                                     (1)..................             (2)     (1)*(2)=(3)  (4) \8\..............  (3)*(4)=(5)..........         (5)/(1)
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                                                                 Reporting Requirements
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PRC-023-4..........................  741 (TO, GO, DP, PC).               1             741  42.445 hrs.; $2,840..  31,452 hrs.;                   $2,840
                                                                                $2,104,139.
PRC-002-2..........................  521 (TO, GO).........               1             521  73.729 hrs.; $4,932..  38,413 hrs.;                    4,932
                                                                                $2,569,830.
PRC-006-2..........................  80 (TO, DP)..........               1              80  47 hrs.; $3,144......  3,760 hrs.; $251,544.           3,144
PRC-012-2..........................  3,291 (RC, PC, TO,                  1           3,291  23.746 hrs.; $1,589..  78,147 hrs.;                    1,589
                                      GO, DP).                                                                      $5,228,034.
PRC-019-1..........................  738 (GO, TO).........               1             738  17 hrs.; $1,137......  12,546 hrs.; $839,327           1,137
PRC-024-1..........................  738 (GO).............               1             738  17 hrs.; $1,137......  12,546 hrs.; $839,327           1,137
PRC-025-1..........................  1,019 (GO, TO, DP)...               1           1,019  6.622 hrs.; $443.....  6,748 hrs.; $451,441.             443
PRC-026-1..........................  1,092 (GO, PC, TO)...               1           1,092  7.868 hrs.; $1,092...  8,592 hrs.; $574,805.           1.092
PRC-027-1..........................  1,727 (TO, GO, DP)...               1           1,727  19.757 hrs.; $1,322..  34,120 hrs.;                    1,322
                                                                                $2,282,628.
PRC-004-5(i) \9\ (formerly in FERC-  648 (TO, GO, DP).....               1             648  8 hrs.\10\; $535.....  5,184 hrs.; $346,810.             535
 725G1).
PRC-010-2 (formerly in FERC-725G4).  26 (PC, TP, DP)......               1              26  36 hrs.; $2,408......  936 hrs.; $62,618....           2,408
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                                                    Record-Keeping (Evidence Retention) Requirements
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PRC-023-4..........................  741 (TO, GO, DP, PC).               1             741  513.858 hrs.; $20,390  380,769 hrs.;                  20,390
                                                                                $15,108,914.
PRC-002-2..........................  521 (TO, GO).........               1             521  31.599 hrs.; $1,254..  16,463 hrs.; $653,252           1,254
PRC-006-2..........................  80 (TO, DP)..........               1              80  5 hrs.; $198.........  400 hrs.; $15,872....             198
PRC-012-2..........................  3,291 (RC, PC, TO,                  1           3,291  11.754 hrs.; $466....  38,684 hrs.;                      466
                                      GO, DP).                                                                      $1,543,981.
PRC-019-2..........................  738 (GO, TO).........               1             738  0 hrs.; $0...........  0 hrs.; $0...........               0
PRC-024-1..........................  738 (GO).............               1             738  0 hrs.; $0...........  0 hrs.; $0...........               0
PRC-025-1..........................  1,019 (GO, TO, DP)...               1           1,019  2.044 hrs.; $81......  2,083 hrs.; $82,653..              81
PRC-026-1..........................  1,092 (GO, PC, TO)...               1           1,092  12 hrs.; $476........  13,104 hrs.; $519,967             476
PRC-027-1..........................  1,727 (TO, GO, DP)...               1           1,727  15.854 hrs.; $629....  27,380 hrs.;                      629
                                                                                $1,086,438.
PRC-004-5(i) (formerly in FERC-      648 (TO, GO, DP).....               1             648  12 hrs.; $476........  7,776 hrs.; $308,552.             476
 725G1).
PRC-010-2 (formerly in FERC-725G4).  26 (PC, TP, DP)......               1              26  12 hrs.; $476........  312 hrs.; $12,380....             476
                                    --------------------------------------------------------------------------------------------------------------------
    Subtotal for Reporting           .....................  ..............  ..............  .....................  232,444 hrs.;          ..............
     Requirements.                                                                                $15,550,504.
    Subtotal for Record-keeping      .....................  ..............  ..............  .....................  486,971 hrs.;          ..............
     Requirements.                                                                                $19,323,009.
        Total......................  .....................  ..............  ..............  .....................  719,415 hrs.;          ..............
                                                                                $34,873,513.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \7\ GO = generator owner, TO = transmission owner, DP =
distribution planner; PC = planning coordinator and TP =
transmission planners, RC = Reliability Coordinator.
    \8\ The average costs per response are rounded to the nearest
dollar.
    \9\ Reliability Standard PRC-004-5(i) is an updated standard
that neither added nor removed reporting and record keeping
requirements (and corresponding burden) as compared to Reliability
Standards PRC-004-3 and PRC-004-4.
    \10\ The reporting requirements for Reliability Standards PRC-
004-5(i) are reduced by 2 hours/response (annually) due to
completion of a one-time requirement imposed by the Order in Docket
No. RD14-14-000).

     Dated: October 12, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-22611 Filed 10-16-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Proposed Rules]
[Pages 24656-24661]
[FR Doc No: 2014-09862]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0081]
RIN 1625-AA00

Safety Zones; Annual Events in the Captain of the Port Zone
Buffalo

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Coast Guard proposes to amend its safety zones regulations
for annually reoccurring firework displays and marine events within the
Captain of the Port Zone Buffalo. The safety zones that would be
amended or established by this proposed rulemaking are necessary to
protect the surrounding public, spectators, participants, and vessels
from the hazards associated with fireworks displays, hydroplane boat
races, and other events of a similar nature posing a potential hazard
to the safety of life and property on the navigable waters. This
proposed rule is intended to restrict vessels from designated areas on
navigable waterways during these events.

DATES: Comments and related materials must be received by the Coast
Guard on or before June 2, 2014.

ADDRESSES: You may submit comments identified by docket number USCG-
2014-0081 using any one of the following methods:
    (1) Federal Rulemaking 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) Delivery: At the 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 on this rule,
call or email LT Christopher Mercurio, Chief of Waterways Management,
U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NAD 83 North American Datum of 1983 Section

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2014-0081), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online at http://www.regulations.gov or by fax, mail, or hand delivery,
but please use only one of these means. If you submit a

comment online, it will be considered received by the Coast Guard when
the comment is successfully transmitted. If you fax, hand deliver, or
mail your comment, it will be considered received by the Coast Guard
when the comment is received at the Docket Management Facility. We
recommend that you include your name and mailing address, an email
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,
type the docket number [USCG-2014-0081] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this notice of proposed rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments 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 and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2014-0081) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. 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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    The regulations found in 33 CFR 165.939 serve to protect the
boating public from hazards associated with firework displays that take
place on a navigable waterway within the Captain of the Port (COTP)
Zone Buffalo. For boundaries of this COTP zone, see 33 CFR 3.45-10. In
2013, the Captain of the Port Buffalo amended the regulations found in
33 CFR 165.939 through a final rule published April 23, 2013 (78 FR
23850). Those revisions clarified the locations of many outdated safety
zones and established seven additional safety zones within the Captain
of the Port Zone Buffalo area of responsibility.

C. Basis and Purpose

    Section 165.939 currently lists 29 permanent safety zones within
the Captain of the Port Zone Buffalo. Each of these 29 safety zones
corresponds to an annually recurring fireworks display.
    After the recent 2013 summer season it was noted the effective
times and dates published for these events were not always rigidly
adhered to by fireworks sponsors and event organizers and thus a
subsequent regulatory update enacting greater regulatory flexibility
for enforcement notification was desired in order to maximize Coast
Guard efficiency and public safety. Also, the COTP Buffalo has decided
to propose safety zones for one additional firework display and five
additional marine events.
    With the above findings in mind, the Coast Guard proposes to amend
33 CFR 165.939 to revise the enforcement period and include several
non-fireworks events.
    The Captain of the Port Buffalo has determined that these events
present significant hazards to public spectators and participants. Such
hazards include premature detonations, dangerous detonations, dangerous
projectiles, falling or burning debris, vessels of unique design
operating at great speed, and large numbers of competitive swimmers.

D. Discussion of Proposed Rule

    For all of the above reasons, the Captain of the Port Sector
Buffalo proposes to revise 33 CFR 165.939. This revision would amend
the verbiage on the enforcement period for all 29 safety zones
currently listed and establish six additional safety zones in Sec.
165.939. These new safety zones would be added as paragraphs (30)
Thunder on the Niagara Hydroplane boat races, North Tonawanda, NY; (31)
Antique Boat Show Hydroplane boat races, Grand Island, NY; (32) D-Day
Conneaut Air show, Conneaut, OH; (33) Bay Swim, Erie, PA; (34) Rover
Fest fireworks display, Cleveland, OH; and (35) Cleveland National Air
show, Cleveland, OH. Although this proposed rule would remain in effect
throughout the year, the safety zones within it will be enforced only
before and during each corresponding event.
    The Captain of the Port will use all appropriate means to notify
the public when the zones in this proposal will be enforced. Consistent
with 33 CFR 165.7(a), such means will include, among other things,
publication in the Federal Register and Broadcast Notice to Mariners.
    Entry into, transiting, or anchoring within the proposed safety
zones would be prohibited unless authorized by the Captain of the Port
Buffalo or his on-scene representative. The Captain of the Port or his
on-scene representative may be contacted via VHF Channel 16.

E. Regulatory Analyses

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

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). We conclude that this proposed
rule is not a significant regulatory action because we anticipate that
it will have minimal impact on the economy, will not interfere with
other agencies, will not adversely alter the budget of any grant or
loan recipients, and will not raise any novel legal or policy issues.
The safety zones contained in this proposed rule will be relatively
small and enforced for relatively short time. Also, the proposed safety
zones are designed to minimize their impact on navigable waters.
Furthermore, the

proposed safety zones have been designed to allow vessels to transit
around them. Thus, restrictions on vessel movement within a particular
area are expected to be minimal. Under certain conditions, moreover,
vessels may still transit through the safety zones when permitted by
the Captain of the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners and operators of vessels
intending to transit or anchor in any one of the proposed safety zones
while these zones are being enforced. These safety zones will not have
a significant economic impact on a substantial number of small entities
for the following reasons: Each safety zone in this proposed rule will
be in enforced for no more than 10 hours in any 24-hour period with the
majority of zones only being in enforced for a few hours in any 24 hour
period. Each of the safety zones will be enforced only once per year
and will be in areas with low commercial vessel traffic. Furthermore,
these safety zones have been designed to allow traffic to pass safely
around each zone. In the event that a safety zone affects shipping,
commercial vessels may request permission from the Captain of the Port
Buffalo or his or her designated representative to transit the safety
zone.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. 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.

4. 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-
3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. 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.

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

    This proposed 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.

10. Protection of Children From Environmental Health Risks

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

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. 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 figure 2-1, paragraph (34) (g), of the
Commandant Instruction because it involves the establishment of a
safety zone.
    A preliminary environmental analysis checklist and a preliminary
categorical exclusion determination are available in

the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR parts 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; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Revise Sec.  165.939 to read as follows:

Sec.  165.939  Safety Zones; Annual Events in the Captain of the Port
Buffalo Zone.

    (a) Safety Zones. The following are designated as safety zones. The
enforcement dates and times for each of the safety zones listed in this
section are subject to change, but the duration of enforcement would
remain the same or nearly the same as the total number of hours as
published. In the event of a change, the Captain of the Port Sector
Buffalo will provide notice to the public by publishing a Notice of
Enforcement in the Federal Register, as well as, issuing a Broadcast
Notice to Mariners.
    (1) Boldt Castle 4th of July Fireworks, Heart Island, NY. (i)
Location. All U.S. waters of the Saint Lawrence River within a 1,120
foot radius of land position 44[deg]20'38.5'' N, 075[deg]55'19.1'' W
(NAD 83) at Heart Island, NY.
    (ii) Enforcement period. July 4 from 8:30 p.m. to 10:30 p.m. each
year.
    (2) Clayton Chamber of Commerce Fireworks, Calumet Island, NY. (i)
Location. All U.S. waters of the Saint Lawrence River within an 840
foot radius of land position 44[deg]15'04'' N, 076[deg]05'40'' W (NAD
83) at Calumet Island, NY.
    (ii) Enforcement period. July 3 from 9 p.m. to 11:30 p.m. of each
year.
    (3) French Festival Fireworks, Cape Vincent, NY. (i) Location. All
U.S. waters of the Saint Lawrence River within an 840 foot radius of
land position 44[deg]07'54.6'' N, 076[deg]20'01.3'' W (NAD 83) in Cape
Vincent, NY.
    (ii) Enforcement period. The second weekend of July from 9:15 p.m.
to 11 p.m. each year.
    (4) Lyme Community Days, Chaumont, NY. (i) Location. All U.S.
waters of Chaumont Bay within a 560 foot radius of position
44[deg]04'06.3'' N, 076[deg]08'56.8'' W (NAD 83) in Chaumont, NY.
    (ii) Enforcement period. The fourth weekend of July from 8:30 p.m.
to 11 p.m. each year.
    (5) Village Fireworks, Sackets Harbor, NY. (i) Location. All U.S.
waters of Black River Bay within an 840 foot radius of position
43[deg]56'51.9'' N, 076[deg]0746.9'' W (NAD 83) in Sackets Harbor, NY.
    (ii) Enforcement period. July 4 from 8:30 p.m. to 10:30 p.m. each
year.
    (6) Can-Am Festival, Sackets Harbor, NY. (i) Location. All U.S.
waters of Black River Bay within a 1,120 foot radius of position
43[deg]57'15.9'' N, 076[deg]06'39.2'' W (NAD 83) in Sackets Harbor, NY.
    (ii) Enforcement period. The third weekend of July from 9 p.m. to
10:45 p.m. each year.
    (7) Oswego Harborfest, Oswego, NY. (i) Location. All U.S. waters of
Lake Ontario within a 1,000 foot radius of position 43[deg]28'10'' N,
076[deg]31'04'' W (NAD 83) in Oswego, NY.
    (ii) Enforcement period. The last Saturday of July from 9 to 10:30
p.m. each year.
    (8) Brewerton Fireworks, Brewerton, NY. (i) Location. All U.S.
waters of Lake Oneida within an 840 foot radius of barge position
43[deg]14'16.4'' N, 076[deg]08'03.6'' W (NAD 83) in Brewerton, NY.
    (ii) Enforcement period. July 3 from 9 p.m. to 10:30 p.m. each
year.
    (9) Celebrate Baldwinsville Fireworks, Baldwinsville, NY. (i)
Location. All U.S. waters of the Seneca River within a 700 foot radius
of land position 43[deg]09'24.9'' N, 076[deg]20'18.9'' W (NAD 83) in
Baldwinsville, NY.
    (ii) Enforcement period. The first weekend of July from 9 p.m. to
11 p.m. each year.
    (10) Island Festival Fireworks, Baldwinsville, NY. (i) Location.
All U.S. waters of the Seneca River within a 1,120 foot radius of land
position 43[deg]09'22'' N, 076[deg]20'15'' W (NAD 83) in Baldwinsville,
NY.
    (ii) Enforcement period. The first weekend of July from 9:30 p.m.
to 11 p.m. each year.
    (11) Seneca River Days, Baldwinsville, NY. (i) Location. All U.S.
waters of the Seneca River within an 840 foot radius of land position
43[deg]09'25'' N, 076[deg]20'21'' W (NAD 83) in Baldwinsville, NY.
    (ii) Enforcement period. The second weekend of July from 9 p.m. to
10:30 p.m. each year.
    (12) City of Syracuse Fireworks Celebration, Syracuse, NY. (i)
Location. All U.S. waters of Onondaga Lake within a 350 foot radius of
land position 43[deg]03'37'' N, 076[deg]09'59'' W (NAD 83) in Syracuse,
NY.
    (ii) Enforcement period. The last weekend of June from 9:30 p.m. to
10:30 p.m. each year.
    (13) Tom Graves Memorial Fireworks, Port Bay, NY. (i) Location. All
U.S. waters of Port Bay within an 840 foot radius of barge position
43[deg]18'14.8'' N, 076[deg]50'17.3'' W (NAD 83) in Port Bay, NY.
    (ii) Enforcement period. July 3 from 9 p.m. to 10:30 p.m. of each
year.
    (14) Village Fireworks, Sodus Point, NY. (i) Location. All U.S.
waters of Sodus Bay within a 1,120 foot radius of land position
43[deg]16'28.7'' N, 076[deg]58'27.5'' W (NAD 83) in Sodus Point, NY.
    (ii) Enforcement period. July 3 from 9:30 p.m. to 10:30 p.m. each
year.
    (15) Rochester Harbor and Carousel Festival, Rochester, NY. (i)
Location. All U.S. waters of Lake Ontario within a 1,120 foot radius of
land position 43[deg]15'40.2'' N, 077[deg]36'05.1'' W (NAD 83) in
Rochester, NY.
    (ii) Enforcement period. The fourth Monday of June from 8 p.m. to
10 p.m. each year.
    (16) A Salute to our Heroes, Hamlin Beach State Park, NY. (i)
Location. All U.S. waters of Lake Ontario within a 560 foot radius of
land position 43[deg]21'51.9'' N, 077[deg]56'59.6'' W (NAD 83) in
Hamlin, NY.
    (ii) Enforcement period. The first weekend of July from 9:45 p.m.
to 11:30 p.m. each year.
    (17) Olcott Fireworks, Olcott, NY. (i) Location. All U.S. waters of
Lake Ontario within a 1,120 foot radius of land position
43[deg]20'23.6'' N, 078[deg]43'09.5'' W (NAD 83) in Olcott, NY.
    (ii) Enforcement period. July 3 from 9:30 p.m. to 11 p.m. of each
year.
    (18) North Tonawanda Fireworks, North Tonawanda, NY. (i) Location.
All U.S. waters of the East Niagara River within a 1,400 foot radius of
land position 43[deg]01'39.6'' N, 078[deg]53'07.5'' W (NAD 83) in North
Tonawanda, NY.
    (ii) Enforcement period. July 4 from 8:45 p.m. to 10:15 p.m. of
each year.
    (19) Tonawanda's Canal Fest Fireworks, Tonawanda, NY. (i) Location.
All U.S. waters of the East Niagara River within a 210 foot radius of
land position 43[deg]01'17.8'' N, 078[deg]52'40.9'' W (NAD 83) in
Tonawanda, NY.
    (ii) Enforcement period. The fourth Sunday of July from 9 p.m. to
10:30 p.m. each year.
    (20) Celebrate Erie Fireworks, Erie, PA. (i) Location. All U.S.
waters of Presque Isle Bay within an 800 foot radius of land position
42[deg]08'19'' N, 080[deg]05'29'' W (NAD 83) in Erie, PA.

    (ii) Enforcement period. The third weekend of August from 9:45 p.m.
to 10:30 p.m. each year.
    (21) Conneaut Fourth of July Fireworks, Conneaut, OH. (i) Location.
All U.S. waters of Lake Erie within an 840 foot radius of position
41[deg]58'01.3'' N, 080[deg]33'39.5'' W (NAD 83) in Erie, PA.
    (ii) Enforcement period. The first Sunday of July from 9 p.m. to
11:30 p.m. each year.
    (22) Fairport Harbor Mardi Gras, Fairport, OH. (i) Location. All
U.S. waters of Lake Erie within a 350 foot radius of land position
41[deg]45'30'' N, 081[deg]16'18'' W (NAD 83) east of the harbor
entrance at Fairport Harbor Beach, OH.
    (ii) Enforcement period. The beginning of the second week of July
from 9 p.m. to 10:30 p.m. each year.
    (23) Mentor Harbor Yacht Club Fireworks, Mentor Harbor, OH. (i)
Location. All U.S. waters of Lake Erie and Mentor Harbor within a 700
foot radius of land position 41[deg]43'36'' N, 081[deg]21'09'' W (NAD
83) in Mentor Harbor, OH.
    (ii) Enforcement period. July 3 from 9 p.m. to 10:30 p.m. each
year.
    (24) Browns Football Halftime Fireworks, Cleveland, OH. (i)
Location. All U.S. waters of Cleveland Harbor and Lake Erie encompassed
by a line beginning at approximate land position 41[deg]30'49.4'' N,
081[deg]41'37.2'' W (the northwest corner of Burke Lakefront Airport);
continuing northwest to 41[deg]31'10.6'' N, 081[deg]41'53.0'' W; then
southwest to 41[deg]30'48.6'' N, 081[deg]42'30.9'' W (the northwest
corner of dock 28 at the Cleveland Port Authority) then northeast back
to the starting point at 41[deg]30'49.4'' N, 081[deg]41'37.2'' W (NAD
83).
    (ii) Enforcement period. On a Sunday during the second or third
Cleveland Browns home game each year. The Captain of the Port will
issue a Notice of Enforcement each year for this Browns Football
Halftime Fireworks' safety zone.
    (25) City of Cleveland 4th of July, Cleveland, OH. (i) Location.
All U.S. waters of Lake Erie and Cleveland Harbor within a 1,000 foot
radius of land position 41[deg]30'10'' N, 081[deg]42'36'' W (NAD 83) at
Dock 20 in Cleveland, OH.
    (ii) Enforcement period. July 4 from 9:30 p.m. to 11 p.m. each
year.
    (26) Cleveland Yachting Club Fireworks Display, Rocky River, OH.
(i) Location. All U.S. waters of the Rocky River and Lake Erie within a
560 foot radius of land position 41[deg]29'25.7'' N, 081[deg]50'18.5''
W (NAD 83), at Sunset Point on the western side of the mouth of the
Rocky River in Cleveland, OH.
    (ii) Enforcement period. The second Thursday of July from 9:15 p.m.
to 11 p.m. each year.
    (27) Sheffield Lake Fireworks, Sheffield Lake, OH. (i) Location.
All U.S. waters of Lake Erie within a 700 foot radius of land position
41[deg]29'26.2'' N, 082[deg]06'47.7'' W (NAD 83), at the lake front
area in Sheffield Lake, OH.
    (ii) Enforcement period. The second Friday of July from 9:30 p.m.
to 11 p.m. each year.
    (28) Lorain 4th of July Celebration Fireworks, Lorain, OH. (i)
Location. All U.S. waters of Lorain Harbor within a 1,400 foot radius
of land position 41[deg]28'35.5'' N, 082[deg]10'51.3'' W (NAD 83), east
of the harbor entrance on the end of the break wall near Spitzer's
Marina.
    (ii) Enforcement period. July 4 from 9:15 p.m. to 11 p.m. each
year.
    (29) Lorain Port Fest Fireworks Display, Lorain, OH. (i) Location.
All U.S. waters of Lorain Harbor within a 750 foot radius of land
position 41[deg]28'02.4'' N, 082[deg]10'21.9'' W (NAD 83) in Lorain,
OH.
    (ii) Enforcement period. The third weekend of July from 9:45 p.m.
to 11 p.m. each year.
    (30) Thunder of the Niagara Hydroplane boat races, North Tonawanda,
NY. (i) Location. All U.S. waters of Niagara River, near North
Tonawanda, NY within 2 miles of the North Grand Island Bridge,
encompassed by a line starting at 43[deg]03'32.95'' N,
078[deg]54'46.93'' W; to 43[deg]03'14.55'' N, 078[deg]55'15.97'' W;
then to 43[deg]02'39.72'' N, 078[deg]54'13.05'' W; then to
43[deg]02'59.99'' N, 078[deg]53'41.99'' W; and returning to the point
of origin (NAD 83).
    (ii) Enforcement period. The second of weekend of August from 9
a.m. to 5 p.m. each year.
    (31) Antique Boat Show Hydroplane boat races, Grand Island, NY. (i)
Location. All waters of Niagara River, Grand Island, NY encompassed by
a line starting at position 42[deg]59'59'' N, 078[deg]56'22'' W; East
to 49[deg]59'54'' N, 078[deg]56'14'' W; South to 42[deg]57'54'' N,
078[deg]56'04'' W; West to 42[deg]057'48'' N, 078[deg]56'22'' W; and
returning to the point of origin (NAD 83).
    (ii) Enforcement period. The first weekend of September from 9 a.m.
to 4 p.m. each year.
    (32) D-Day Conneaut Air Show, Conneaut, OH. (i) Location. All U.S.
waters of Conneaut Township Park, Lake Erie, Conneaut, OH encompassed
by a line starting at 41[deg]57.71' N, 080[deg]34.18' W; to
41[deg]58.36' N, 080[deg]34.17' W; to 41[deg]58.53' N, 080[deg]33.55'
W; to 41[deg]58.03' N, 080[deg]33.72' W; and returning to the point of
origin. (NAD 83).
    (ii) Enforcement period. The third weekend of August from 1:45 p.m.
to 5:30 p.m. each year.
    (33) Bay Swim, Erie, PA. (i) Location. All U.S. waters of Presque
Isle Bay, Erie, PA within a 1000 feet of a line starting at Vista 3 in
Presque Isle State Park at position 42[deg]07'29.30'' N,
80[deg]08'48.82'' W and ending at to the Erie Yacht Club at position
42[deg]07'21.74'' N, 80[deg]07'58.30'' W (NAD 83).
    (ii) Enforcement period. The third week in June each year.
    (34) Rover Fest fireworks display, Cleveland, OH. (i) Location. All
U.S. waters of Lake Erie, Cleveland, OH within a 280 foot radius from
position 41[deg]30'34.23'' N and 081[deg]41'55.73'' W (NAD 83).
    (ii) Enforcement period. The second or third weekend of July each
year.
    (35) Cleveland National Air show, Cleveland, OH. (i) Location. The
safety zone encompass the portion of Lake Erie and Cleveland Harbor
within a line originating near Burke Lakefront Airport from position
41[deg]30'20'' N and 081[deg]42'20'' W to 41[deg]30'50'' N and
081[deg]42'49'' W, to 41[deg]32'09'' N and 081[deg]39'49'' W, to
41[deg]31'53'' N and 081[deg]39'24'' W, then return to the original
position (NAD 83).
    (ii) Enforcement period. On the Friday before Labor Day through the
Wednesday following Labor Day with maximum daily times from 8 a.m. to 6
p.m.. The daily time period will be reduced as operations permit.
    (b) Definitions. The following definitions apply to this section:
    (1) ``On-scene Representative'' means any Coast Guard commissioned,
warrant, or petty officer designated by the Captain of the Port Buffalo
to monitor a safety zone, permit entry into the zone, give legally
enforceable orders to persons or vessels within the zones, and take
other actions authorized by the Captain of the Port.
    (2) ``Public vessel'' means vessels owned, chartered, or operated
by the United States, or by a State or political subdivision thereof.
    (c) Regulations. In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within is the
aforementioned safety zones are prohibited unless authorized by the
Captain of the Port Buffalo or his designated on-scene representative.
    (1) The safety zones described in paragraph (a) of this section are
closed to all vessel traffic, except as may be permitted by the Captain
of the Port Buffalo or his designated on-scene representative.

    (3) Vessel operators desiring to enter or operate within the safety
zones described in paragraph (a) of this section must contact the
Captain of the Port Buffalo or his on-scene representative to obtain
permission to do so. The Captain of the Port Buffalo or his on-scene
representative may be contacted via VHF Channel 16. Vessel operators
given permission to enter or operate in a safety zone must comply with
all directions given to them by the Captain of the Port Buffalo, or his
on-scene representative.
    (d) Exemption. Public vessels, as defined in paragraph (c) of this
section, are exempt from the requirements in this section.
    (e) Waiver. For any vessel, the Captain of the Port Buffalo or his
designated representative may waive any of the requirements of this
section, upon finding that operational conditions or other
circumstances are such that application of this section is unnecessary
or impractical for the purposes of public or environmental safety.
    (f) Notification. The Captain of the Port Buffalo will notify the
public that the safety zones in this section are or will be enforced by
all appropriate means to the affected segments of the through
publication in the Federal Register as practicable, in accordance with
33 CFR 165.7(a). Additionally, the enforcement dates and times for each
of the safety zones listed above are subject to change, though the
duration of enforcement would remain the same or nearly the same total
number of hours as stated above. In either event, whether the safety
zones occur at the dates and times as stated above, or whether the date
or time of a safety zone changes, the Captain of the Port Buffalo will
similarly make such notification as described in this paragraph (f).
Such means of further notification may also include, but are not
limited to Broadcast Notice to Mariners or Local Notice to Mariners.
The Captain of the Port will issue a Broadcast Notice to Mariners
notifying the public when enforcement of the safety zone is cancelled.

    Dated: March 12, 2014.
B.W. Roche,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2014-09862 Filed 4-30-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63892-63894]
[FR Doc No: 2018-26900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4267]

Biomarker Qualification: Evidentiary Framework; 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 or Agency) is announcing
the availability of a draft guidance for industry and FDA staff
entitled ``Biomarker Qualification: Evidentiary Framework.'' This draft
guidance provides recommendations on general considerations to address
when developing a biomarker for qualification under the 21st Century
Cures Act (Cures Act), enacted on December 13, 2016, that added a new
section to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Qualification of a biomarker is a determination that within the stated
context of use, the biomarker can be relied on to have a specific
interpretation and application in drug development and regulatory
review.

DATES: Submit either electronic or written comments on the draft
guidance by February 11, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4267 for ``Biomarker Qualification: Evidentiary Framework;
Draft Guidance for Industry and FDA Staff.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/

fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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: Chris Leptak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Biomarker Qualification: Evidentiary
Framework.'' This draft guidance provides recommendations on general
considerations to address when developing a biomarker for qualification
under the Cures Act, enacted on December 13, 2016, that added a new
section 507, Qualification of Drug Development Tools, to the FD&C Act
(21 U.S.C. 357).\1\ This guidance discusses the evidentiary framework
that should be used to support biomarker qualification, as that term is
now used in section 507 of the FD&C Act, and it was informed by public
workshops that predated the Cures Act. Specifically, this guidance
describes the needs assessment, context of use, and benefit-risk
considerations, and how these considerations can relate to determining
the type and level of evidence to support qualification of a biomarker.
This guidance also addresses general statistical and clinical
considerations related to the correlation between the biomarker and the
outcome of interest, as well as general analytical considerations
related to the performance characteristics of the biomarker test.
---------------------------------------------------------------------------

    \1\ Section 507 of the FD&C Act was added by section 3011(a) of
the Cures Act (Pub. L. 114-255).
---------------------------------------------------------------------------

    Historically, biomarkers gained acceptance for use in drug
development after evidence from scientific and medical communities
accumulated over time, leading to the recognition of the role and value
of the biomarker in decision making. This evidence was considered as
part of drug-specific development efforts, and there was no formal
regulatory process to assess the broader utility of the biomarker
independent from its use in a specific drug program. Even after the
Center for Drug Evaluation and Research established the legacy (pre-
Cures Act) Biomarker Qualification Program in 2007, progress in the
development of biomarkers and their application in drug development has
been hampered by the lack of a clear, predictable, and specific
regulatory framework for the evidence sufficient to support regulatory
decision making using biomarkers. This guidance is an additional step
towards informing future guidances that will specifically address this
need, the Cures Act requirements, and commitments from the Prescription
Drug User Fee Reauthorization Performance Goals and Procedures Fiscal
Years 2018 through 2022 (PDUFA VI goals letter) \2\.
---------------------------------------------------------------------------

    \2\ The PDUFA VI goals letter is available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.
---------------------------------------------------------------------------

    This guidance was informed by several public workshops \3\ that
discussed the science to support biomarker qualification; these
workshops convened before the enactment of the Cures Act. Development
of this guidance was also greatly facilitated by the efforts from the
biomarker development community--including FDA, National Institutes of
Health (NIH), industry, academia, patient groups, and the nonprofit
sector--that developed an October 2016 white paper describing a
Framework for Defining Evidentiary Criteria for Biomarker
Qualification.\4\ In addition to considering public comments received
regarding this guidance, FDA anticipates that the Agency will
incorporate additional information required under the Cures Act and
discussed in the PDUFA VI goals letter in a subsequent revised draft
version of this guidance. Ultimately, FDA anticipates that a future
revised draft guidance on this topic will meet the statutory
requirement for guidance on a conceptual framework describing
appropriate standards and scientific approaches to support the
development of biomarkers as described in section 3011(b)(1)(A) of the
Cures Act and meet the commitment in section (1)(J)(6)(d) of the PDUFA
VI goals letter related to publishing a draft guidance on general
evidentiary standards for biomarker qualification. As part of FDA's
efforts to delineate the conceptual framework to support biomarker
qualification and the general evidentiary standards for biomarker
qualification, FDA also anticipates that subsequent guidance on
biomarker qualification will address specific aspects of evidentiary
considerations (e.g., statistical, analytical) in greater detail. This
draft guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115).
---------------------------------------------------------------------------

    \3\ Workshops convened to discuss the science to support
biomarker qualification included: Institute of Medicine Workshop on
Biomarker Qualification (2009), FDA co-sponsored Biomarkers Workshop
with Howard Hughes Medical Institute (2013), FDA co-sponsored
Brookings meeting on Advancing the Use of Biomarkers and
Pharmacogenomics (2014), FDA co-sponsored workshop with M-CERSI and
the Critical Path Institute on Evidentiary Considerations for
Integration of Biomarkers in Drug Development (2015), NIH-FDA
Workshop on Biomarker Glossary of Terms (2015), the National
Biomarker Development Alliance's Workshop on Collaboratively
Building a Foundation for FDA Biomarker Qualification (2015), and
Foundation for the NIH-FDA Workshop on Developing an Evidentiary
Criteria Framework for Safety Biomarkers Qualification (2016).
    \4\ Biomarkers Consortium Evidentiary Standards Writing Group:
Framework for Defining Evidentiary Criteria for Biomarker
Qualification. Final version October 20, 2016. Available at: https://fnih.org/sites/default/files/final/pdf/Evidentiary%20Criteria%20Framework%20Final%20Version%20Oct%2020%202016.pdf.
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    The draft guidance, when finalized, will represent the current
thinking of FDA on ``Biomarker Qualification: Evidentiary Framework.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26900 Filed 12-11-18; 8:45 am]
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