[Federal Register Volume 85, Number 120 (Monday, June 22, 2020)]
[Proposed Rules]
[Pages 37397-37399]
[FR Doc No: 2020-13128]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0247]
RIN 1625-AA00

Safety Zone; I-5 Bridge Construction Project, Columbia River,
Vancouver, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of the Columbia River. This action is necessary
to provide for the safety of life on these navigable waters around the
Northbound Interstate Bridge at Columbia River Mile 106.5. This
proposed rulemaking would prohibit persons and vessels from being in
the safety zone unless authorized by the Captain of the Port Sector
Columbia River or a designated representative. We invite your comments
on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before July 22, 2020.

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0247 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Commander Dixon Whitley,
Waterways Management Division, Marine Safety Unit Portland, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background, Purpose, and Legal Basis

    On September 6, 2020, through September 26, 2020, the Oregon
Department of Transportation is scheduled replace bridge components at
the south end of the Northbound Interstate Bridge over the Columbia
River at River Mile 106.5. As a result, a large construction crane
barge blocking the navigable channel will be moving oversized equipment
and bridge parts overhead and across the waterway resulting in
potential hazards to the waterway and its users. The Captain of Port
Sector Columbia River has determined that the potential hazards
associated with the construction project would be a safety concern for
anyone within the designated area of the I-5 bridge construction
project.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within the designated area of the I-5 bridge
construction project.
    The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 12:01 on
September 6, 2020 through 11:59 p.m. on September 26, 2020. The safety
zone would cover all navigable waters of the Columbia River, directly
below the lifting span of the I-5 bridge from the Washington shoreline
to the edge of the lifting span (approx. 800 ft) and approximately 400
ft both east and west of the bridge. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters
while the bridge construction is underway. No vessel or person would be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative. The regulatory text we are
proposing appears at the end of this document.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory

approaches that maximize net benefits. Executive Order 13771 directs
agencies to control regulatory costs through a budgeting process. This
NPRM has not been designated a ``significant regulatory action,'' under
Executive Order 12866. Accordingly, the NPRM has not been reviewed by
the Office of Management and Budget (OMB), and pursuant to OMB guidance
it is exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
would be able to safely transit around this safety zone which would
impact a small designated area of the Columbia River during the bridge
construction project. Moreover, the Coast Guard will issue Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the zone, and the
rule would allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting 20 days that will prohibit vessel traffic to transit
underneath the lift span of the I-5 Bridge during bridge repair and
construction operations. Normally such actions are 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 preliminary
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. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. 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 eRulemaking

System of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM 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.

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 is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  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. 0170.1.

0
2. Add Sec.  165.T13-0247 to read as follows:

Sec.  165.T13-0247   Safety Zone[s]; Safety Zone; I-5 Bridge
Construction Project, Columbia River, Vancouver, WA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Columbia River, surface to bottom, encompassed by a line
connecting the following points beginning at the shoreline at
45[deg]37'17.7'' N/122[deg]40'31.4'' W, southwest to 45[deg]37'12.1''
N/122[deg]40'35.0'' W, southeast to 45[deg]37'08.8'' N/
122[deg]40'22.1'' W, thence northeast to 45[deg]37'15.0'' N/
122[deg]40'18.3'' W, and along the shoreline back to the beginning
point.
    (b) Definitions. As used in this section, designated representative
means any Coast commissioned, warrant, or petty officer who has been
authorized by the Captain of the Port Columbia River (COTP) to act on
his behalf, or a Federal, State, and local officer designated by or
assisting the Captain of the Port Columbia River 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) Vessel operators desiring to enter or operate with the safety
zone may contact the COTP's on-scene designated representative by
calling<PHONE_NUMBER> or the Sector Columbia River Command Center on
Channel 16 VHF-FM. Those in the safety zone must comply with all lawful
orders or directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement period. This safety zone is in effect from 12:01 on
September 6, 2020 through 11:59 p.m. on September 26, 2020. It will be
subject to enforcement this entire period unless the Captain of the
Port, Columbia River determines it is no longer needed. The Coast Guard
will inform mariners of any change to this period of enforcement via
Broadcast Notice to Mariners.

    Dated: May 12, 2020.
J.C. Smith,
Captain, U.S. Coast Guard, Captain of the Port Columbia River.
[FR Doc. 2020-13128 Filed 6-19-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47626-47628]
[FR Doc No: 2018-20502]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3175]

Product Identifiers Under the Drug Supply Chain Security Act
Questions and Answers; Draft 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 draft guidance for industry entitled ``Product
Identifiers Under the Drug Supply Chain Security Act Questions and
Answers.'' This draft guidance intends to clarify questions relating to
product identifiers that are required by the Federal Food, Drug, and
Cosmetic Act

(FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA)
for packages and homogenous cases of certain drug products. Sections of
the FD&C Act require manufacturers and repackagers to affix or imprint
a product identifier to each package and homogenous case of a product
intended to be introduced in a transaction into commerce beginning
November 27, 2017, and November 28, 2018, respectively. This draft
guidance intends to clarify these requirements.

DATES: Submit either electronic or written comments on the draft
guidance by November 19, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
concerning the collection of information proposed in the draft guidance
by November 19, 2018.

ADDRESSES: You may submit comments 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-3175 for ``Product Identifiers Under the Drug Supply Chain
Security Act Questions and Answers.'' 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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tia Harper-Velazquez, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The DSCSA (Title II of Pub. L. 113-54) was signed into law on
November 27, 2013. Section 202 of the DSCSA added section 582 to the
FD&C Act (21 U.S.C. 360eee-1). This section establishes product
tracing, product identifier, and verification requirements for
manufacturers, repackagers, wholesale distributors, and dispensers to
facilitate the tracing of products through the pharmaceutical
distribution supply chain. Failure to comply with the requirements of
section 582 is a prohibited act under section 301(t) of the FD&C Act
(21 U.S.C. 331(t)).
    The effective date for manufacturers to ``affix or imprint a
product identifier to each package and homogenous case of a product
intended to be introduced in a transaction into commerce'' under
section 582(b)(2)(A) of the FD&C Act, is not later than November 27,
2017. In June 2017, FDA published a draft guidance entitled ``Product
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy,'' in which FDA describes its intention regarding the
enforcement of certain product identifiers under the DSCSA. As
described in the draft guidance, FDA does not intend to take action
against manufacturers who do not affix or imprint a product identifier
to each package and homogenous case of products intended to be
introduced in a transaction into commerce before November 26, 2018.
This represents a 1-year delay in enforcement of the requirement for
manufacturers to affix or imprint product identifiers. The

effective date for repackagers to ``affix or imprint a product
identifier to each package and homogenous case of a product intended to
be introduced in a transaction in commerce'' under section 582(e)(2)(A)
of the FD&C Act, is not later than November 27, 2018.
    This guidance is intended to assist manufacturers and repackagers
in understanding the requirements to affix or imprint a product
identifier on each package and homogenous case of product that they
introduce in a transaction into commerce to satisfy the product
identifier requirement of section 582 of the FD&C Act. The
recommendations in this guidance are intended to assist manufacturers
and repackagers in standardizing both the human-readable and machine-
readable format of the information that is contained in the product
identifier. This guidance also intends to clarify that these
requirements do not change the linear barcode requirements.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Product
Identifiers Under the Supply Chain Security Act Questions and
Answers.'' 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 includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520)
(PRA). In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidances.

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: September 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20502 Filed 9-19-18; 8:45 am]
 BILLING CODE 4164-01-P