[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76497-76499]
[FR Doc No: 2022-27133]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0347]

Seventh Coast Guard District Southeast Atlantic Coast Port Access
Route Study: Port Approaches and International Entry and Departure
Transit Areas

AGENCY: Coast Guard, DHS.

ACTION: Notice of study; request for comments.

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SUMMARY: The Coast Guard is beginning a series of studies to gather
more information about routes used by ships, to access ports on the
Southeast Atlantic Coast of the United States. This action is being
taken in support of the provisions provided in Public Law 117-169,
commonly referred to as the Inflation Reduction Act of 2022 (IRA), and
Executive Order on the Implementation of the Energy and Infrastructure
Provisions of the Inflation Reduction Act of 2022 (E.O. 14082). These
studies will be separate from, but may expand upon, the proposals in
the other Coast Guard rulemakings.

DATES: The Coast Guard Seventh District Commander will schedule
individual, localized Port Access Route Studies (PARS) for specific
port approaches and international transit areas to ports on the
Atlantic Coast of South Carolina, Georgia, Florida, Commonwealth of
Puerto Rico, and the U.S. Virgin Islands. This initiative is expected
to be completed by December 2026. Comments and related material must be
received on or before February 13, 2023. Requests for a public meeting
must be submitted on or before January 13, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0347 using the Federal eRulemaking Portal http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTAL INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice or study, call or email LT Ryan Gilbert, Seventh Coast Guard
District (dpw), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

ACPARS Atlantic Coast Port Access Route Study
AIS Automatic Identification System
ANPRM Advanced Notice of Proposed Rulemaking
COMDTINST Commandant Instruction
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
EO Executive Order
FL Florida
FR Federal Register
GA Georgia
IRA Inflation Reduction Act
MTS Marine Transportation System Information Bulletin
PARS Port Access Route Study
NM Nautical Mile
NPRM Notice of Proposed Rulemaking
SC South Carolina
TSS Traffic Separation Scheme
U.S. United States
U.S.C. United States Code

II. Public Participation and Request for Comments

    We encourage you to participate in this study 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.
    A. Submitting Comments: If you submit comments to the online public
docket, please include the docket number for this rulemaking (USCG-
2022-0347), indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. We accept anonymous comments.
    To submit your comment online, go to http://www.regulations.gov,
and insert

``USCG-2022-0347'' in the ``search box.'' Click ``Search''. Then click
``Comment Now.'' We will consider all comments and material received
during the comment period.
    B. Public Meetings: The Coast Guard may hold public meeting(s) if
there is sufficient public interest. You must submit a request for one
on or before January 13, 2023. You may submit your request for a public
meeting online via http://www.regulations.gov. Please explain why you
believe a public meeting would be beneficial. If we determine that a
public meeting would aid in the study, we will hold a meeting at a time
and place announced by a later notice in the Federal Register.
    C. Viewing Comments and Documents: To view the comments and
documents mentioned in this preamble as being available in the docket,
go to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2022-0347'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column.
    D. Privacy Act: We accept anonymous comments. All comments received
will be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions in response to this document, see DHS's
Correspondence System of Records notice (84 FR 48645, September 26,
2018). Documents mentioned in this notice as being available in the
docket, and all public comments, will be in our online docket at
https://www.regulations.gov and can be viewed by following that
website'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.

III. Definitions

    Fairway or shipping safety fairway means a lane or corridor in
which no artificial island or fixed structure, whether temporary or
permanent, will be permitted. See 33 CFR 166.105 (a).
    International Entry and Departure Transit Areas means navigation
routes followed by vessels coming to or departing from the United
States or an international seaport. For these studies, international
entry and departure transit areas will connect to recommend shipping
safety fairways at the outer limit of the U.S. Exclusive Economic Zone
(EEZ).
    Port Approaches mean navigation routes followed by vessels entering
or departing a seaport from or to a primary transit route. These
studies will consider port approaches that connect seaports to
recommended shipping safety fairways described in the Atlantic Coast
Port Access Route Study (ACPARS).

IV. Discussion

    The Coast Guard is beginning a series of new studies regarding port
approaches and international entry and departure transit areas, to
ports on the Atlantic Coast of South Carolina, Georgia, Florida,
Commonwealth of Puerto Rico, and the U.S. Virgin Islands. These routes
are critical links of a robust and effective Marine Transportation
System (MTS) and integral to efficient movement between ports and
shipping safety fairways along the Atlantic Coast.
    Section 50251 of the IRA allows the Department of the Interior to
grant leases, easements, and rights-of-way previously withdrawn in the
Presidential memorandum entitled ``Memorandum on the Withdrawal of
Certain Areas of the United States Outer Continental Shelf from Leasing
Disposition'' and dated September 8, 2020; or the Presidential
memorandum entitled ``Presidential Determination on the Withdrawal of
Certain Areas of the United States Outer Continental Shelf from Leasing
Disposition'' and dated September 25, 2020. Additionally, section 50251
of the IRA expanded the authority under the Outer Continental Shelf
Lands Act to include waters adjacent to any territory of the United
States, specifically the Commonwealth of Puerto Rico. These new studies
are focused on routes between port approaches and international entry
and departure transit areas that would potentially be impacted through
the creation of new, renewable offshore energy projects, created as a
result of the implementation of the IRA.
    The Ports and Waterways Safety Act, (PWSA)(46 U.S.C. 70003(c)(1)),
authorizes the Commandant of the Coast Guard to designate necessary
fairways and traffic separations schemes (TSSs) to provide safe access
routes for vessels proceeding to and from United States ports. The
designation of fairways and TSSs recognizes the paramount right of
navigation over all other uses in the designated areas.
    Before establishing or adjusting fairways, 46 U.S.C. 70003(c)(1)
requires the Coast Guard to study potential traffic density and assess
the need for safe access routes for vessels. During this process, the
Coast Guard considers the views of the maritime community,
environmental groups, and other stakeholders to reconcile the need for
safe access routes with reasonable waterway uses. See 46 U.S.C.
70003(c)(3).
    An analysis of potential traffic density, involving vessels
proceeding to and from a U.S. port, is referred to as a Port Access
Route Study (PARS). Several PARS will examine ports along the Southeast
Atlantic Coast of the U.S. and U.S. Territories that are economically
significant, support military operations, or are critical to national
defense, and related international entry and departure transit areas.
In particular the PARS will study areas that are integral to the safe,
efficient and unimpeded flow of commerce to/from major international
shipping lanes. Similar to the ACPARS, this PARS will use Automatic
Identification System (AIS) data and information from stakeholders to
identify and verify customary navigation routes as well as potential
conflicts involving alternative activities, such as wind energy
generation and offshore mineral exploitation and exploration.

V. Timeline, Scope, and Process

    The Seventh Coast Guard District will conduct this PARS. The study
will commence upon publication of this notice and may take 12 months or
more to complete.
    The study area is bounded by a line connecting the following
geographic positions:
    1. 33[deg]51'7'' N 078[deg]32'27'' W to;
    2. 32[deg]26'38'' N 075[deg]55'34'' W to;
    3. 25[deg]24'28'' N 079[deg]56'37'' W to;
    4. 25[deg]09'2'' N 080[deg]00'15'' W to;
    5. 24[deg]53'1'' N 080[deg]12'27'' W to;
    6. 24[deg]25'53'' N 081[deg]03'18'' W to;
    7. 24[deg]14'49'' N 081[deg]53'7'' W thence following an arc of
12nm around a center point of Loggerhead Key, FL to;
    8. 24[deg]25'7'' N 082[deg]55'50'' W to;
    9. 24[deg]50'16'' N 082[deg]55'29'' W to;
    10. 25[deg]03'31'' N 081[deg]22'23'' W to;
    11. 25[deg]11'41'' N 081[deg]08'51'' W thence following the
coastline back to origin.
    This area extends approximately 185 nautical miles seaward of the
North Carolina/South Carolina Border then approximately follows the
territorial sea from Miami around the Florida Keys. An illustration
showing the study area is available in the docket where indicated under
ADDRESSES. Additionally, the study area is available for viewing on the
Navigation Center's website at: https://www.navcen.uscg.gov/port-access-route-study-reports.
    The Coast Guard will analyze ports that are economically
significant, that support military operations, or are strategic for
national defense along the Southeast Atlantic Coast and U.S.

Territory. This study includes but is not limited to:

--Port of Charleston, SC; Port of Savannah, GA; Port of Brunswick, GA
from January 2023 to December 2023
-- Port of Kings Bay, GA; Port of Jacksonville, FL from January 2024 to
December 2024
-- Port Canaveral, FL; Port Everglades, FL; Port Miami, FL; Port of Key
West from January 2025 to December 2025
-- Ports of the Commonwealth of Puerto Rico and U.S. Virgin Islands
from January 2026 to December 2026

VI. Methodology

    These studies will analyze navigation routes to and from the ports
identified above to their proposed fairways, as well as international
routes to and from the United States. Current capabilities and planned
improvements in these ports to handle maritime conveyances will be
considered. Analyses will be conducted in accordance with Marine
Planning to Operate and Maintain the Marine Transportation System (MTS)
and Implement National Policy, COMDTINST 16003.2B, and coordinated by
the cognizant District Commander. This instruction is available at
https://media.defense.gov/2019/Jul/10/2002155400/-1/-1/0/CI_16003_2B.PDF. Notices of study will be published in the Federal
Register to inform and solicit public comments for each PARS.
    We will publish the results of the PARS in the Federal Register. It
is possible that the study may validate the status quo (no fairways or
routing measures) and conclude that no changes are necessary. It is
also possible that the study may recommend one or more changes to
address navigational safety and the efficiency of vessel traffic
management. The recommendations may lead to future rulemakings or
appropriate international agreements.
    This notice is issued under authority of 46 U.S.C. 70003(c) and 5
U.S.C.552(a).

    Dated: December 9, 2022.
Brendan C. McPherson,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2022-27133 Filed 12-13-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 130 (Friday, July 8, 2022)]
[Rules and Regulations]
[Pages 40723-40725]
[FR Doc No: 2022-14573]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0553]
RIN 1625-AA00

Safety Zone; Pacific Gas and Electric Radiological Barrier
Maintenance, Eureka, CA

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

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of Humboldt Bay in Eureka, CA, in support of the
Pacific Gas and Electric Radiological Barrier Maintenance on July 13,
2022. The safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards created by the dangers
associated with the maintenance, such as radiation exposure.
Unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone without the
permission of the Captain of the Port San Francisco or a designated
representative.

DATES: This rule is effective from 7 a.m. until 5 p.m. on July 13,
2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0553 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Anthony Solares, Sector San Francisco
Waterways Management Division, U.S. Coast Guard; telephone 415-399-
3585, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive final
details for this project until June 24, 2022. It is impracticable to go
through the full notice and comment rule making process because the
Coast Guard must establish this safety zone by July 13, 2022, and lacks
sufficient time to provide a reasonable comment period and to consider
those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is necessary to protect personnel, vessels, and the marine environment
from the potential safety hazards created by the radiological barrier
maintenance beginning on July 13, 2022.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco (COTP) has determined that potential hazards associated with
the movement of radiological shielding barriers starting July 13, 2022,
will be a safety concern for anyone within 200-meters of position:
40[deg]44'31'' N, 124[deg]12'39'' W (NAD83). For this reason, this
temporary safety zone is needed to protect personnel, vessels, and the
marine environment in the navigable waters within the safety zone for
the duration of the barrier maintenance.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7 a.m. until 5 p.m. on
July 13, 2022. The safety zone will cover all navigable waters within
200-meters of position: 40[deg]44'31'' N, 124[deg]12'39'' W (North
American Datum 83 (NAD83)). The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters while radiological material is exposed. A 22,700 pound
lid to one of six fortified storage casks, containing spent nuclear
fuel rods, be lifted for inspection. No vessel or person will be
permitted to enter into, transit through, or remain in the safety zone
without obtaining permission from the COTP or a designated
representative. A ``designated representative'' means a Coast Guard
Patrol Commander, including a Coast Guard coxswain, petty officer, or
other officer operating a Coast Guard vessel, or a Federal, State, or
local officer designated by or assisting the COTP in the enforcement of
the safety zone.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited size,
location, duration, and time-of-day of the safety zone. This safety
zone will impact a small designated area of Humboldt Bay in Eureka, CA.
Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone. Any vessels or persons
desiring to transit through or around the temporary safety zone may do
so upon express permission from the COTP or the COTP's designated
representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the

Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this 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 rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined 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 rule involves a
temporary safety zone lasting ten hours over a single day operation
period that will prohibit entry within 200-meters of position:
40[deg]44'31'' N, 124[deg]12'39'' W (NAD83). It is categorically
excluded from further review under paragraph L60(a) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-105 to read as follows:

Sec.  165.T11-105  Safety Zone; Pacific Gas and Electric Radiological
Barrier Maintenance, Eureka, CA.

    (a) Location. The following area is a safety zone: all navigable
waters of Humboldt Bay in Eureka, CA, from surface to bottom, within a
circle formed by connection of all points 200-meters from position:
40[deg]44'31'' N, 124[deg]12'39'' W (NAD83) or as announced via
Broadcast Notice to Mariners. These coordinates are based on North
American Datum 83 (NAD 83).
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel, or a
Federal, State, and Local officer designated by or assisting the
Captain of the Port San Francisco (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) During the enforcement periods, the safety zone is closed to
all vessel traffic, except as may be permitted by the COTP or the
COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement periods. This section will be enforced from 7 a.m.
until 5 p.m. on July, 13, 2022.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced, in accordance with Sec.  165.7.

    Dated: July 1, 2022.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2022-14573 Filed 7-7-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15581-15583]
[FR Doc No: 2018-07375]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3848]

E11(R1) Addendum: Clinical Investigation of Medicinal Products in
the Pediatric Population; International Council for Harmonisation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``E11(R1)
Addendum: Clinical Investigation of Medicinal Products in the Pediatric
Population'' (E11(R1) addendum or addendum). The guidance was prepared
under the auspices of the International Council for Harmonisation
(ICH), formerly the International Conference on Harmonisation. The
guidance is an addendum to the guidance published in 2000 entitled
``E11 Clinical Investigation of Medicinal Products in the Pediatric
Population'' (ICH E11 (2000)), and provides updates to the original
guidance. This addendum does not alter the scope of the original
guidance, which outlines an approach to the safe, efficient, and
ethical study of medicinal products in the pediatric population. This
addendum complements and provides clarification and current regulatory
perspective on topics in pediatric drug development. The guidance is
intended to provide high-level guidance on the implementation of
important approaches in pediatric drug development. This harmonized
addendum will help to define the current recommendations and reduce the
likelihood that substantial differences will exist among regions for
the acceptance of data generated in pediatric global drug development
programs and ensure timely access to medicines for children.

DATES: The announcement of the guidance is published in the Federal
Register on April 11, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2016-D-3848 for ``E11(R1) Addendum: Clinical Investigation of
Medicinal Products in the Pediatric Population.'' 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 this 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, 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. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Lynne Yao,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Avenue, Bldg. 22, Rm. 6406, Silver Spring, MD
20993-0002,<PHONE_NUMBER>; 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, 240-
402-7911. Regarding the ICH: Amanda Roache, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization, and FDA is committed to seeking scientifically-
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
    The ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. The ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization, and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidances.
    In the Federal Register of November 22, 2016 (81 FR 83847), FDA
published a notice announcing the availability of a draft guidance
entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal
Products in the Pediatric Population.'' The notice gave interested
persons an opportunity to submit comments by February 21, 2017.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in August 2017.
    The E11(R1) addendum provides guidance on pediatric drug
development and is intended to complement and provide clarification and
current regulatory perspectives on topics in pediatric drug development
that were originally presented in ICH E11 (2000). The addendum does not
alter the scope of the original guidance, which outlines an approach to
the safe, efficient, and ethical study of medicinal products in the
pediatric population. In the addendum, section II (2) (ETHICAL
CONSIDERATIONS), section IV (4) (AGE CLASSIFICATION AND PEDIATRIC
SUBGROUPS, INCLUDING NEONATES), and section VII (7) (PEDIATRIC
FORMULATIONS), supplement the content in ICH E11 (2000). Section III
(3) (COMMONALITY OF SCIENTIFIC APPROACH FOR PEDIATRIC DRUG DEVELOPMENT
PROGRAMS) addresses issues to aid scientific discussions at various
stages of pediatric drug development in different regions. Section V
(5) (APPROACHES TO OPTIMIZE PEDIATRIC DRUG DEVELOPMENT) includes
enhancement to the topic of Extrapolation, and introduces Modeling and
Simulation. Section VI (6) (PRACTICALITIES IN THE DESIGN AND EXECUTION
OF PEDIATRIC CLINICAL TRIALS) includes discussion of feasibility,
outcome assessments, and long-term clinical aspects, including

safety. These sections describe essential considerations intended to
provide high-level guidance on the implementation of these approaches
in pediatric drug development and have been revised based on comments
received from global stakeholders.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``E11(R1) Addendum: Clinical Investigation
of Medicinal Products in the Pediatric Population.'' 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. Electronic Access

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

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07375 Filed 4-10-18; 8:45 am]
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