Notice of Agreements Filed, 14202 [2020-05002]
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Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 / Notices
random audits. The random audits are
conducted on the carriers that use
numbering resources in order to verify
the accuracy of numbering data reported
on FCC Form 502, and to monitor
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Federal Communications Commission.
Cecilia Sigmund,
Federal Register Liaison Officer, Office of the
Secretary.
Filing Party: Wayne Rohde; Cozen
O’Connor.
Synopsis: This amendment revises
Article 5.6(c) of the Agreement to
exclude tug services from the services
for which the parties are authorized to
negotiate jointly.
Proposed Effective Date: 3/5/2020.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/2021.
Dated: March 6, 2020.
Rachel Dickon,
Secretary.
[FR Doc. 2020–05002 Filed 3–10–20; 8:45 am]
BILLING CODE 6731–AA–P
[FR Doc. 2020–04967 Filed 3–10–20; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FEDERAL MARITIME COMMISSION
Food and Drug Administration
lotter on DSKBCFDHB2PROD with NOTICES
Notice of Agreements Filed
The Commission hereby gives notice
of the filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit
comments, relevant information, or
documents regarding the agreements to
the Secretary by email at Secretary@
fmc.gov, or by mail, Federal Maritime
Commission, Washington, DC 20573.
Comments will be most helpful to the
Commission if received within 12 days
of the date this notice appears in the
Federal Register. Copies of agreements
are available through the Commission’s
website (www.fmc.gov) or by contacting
the Office of Agreements at (202)–523–
5793 or tradeanalysis@fmc.gov.
Agreement No.: 201334.
Agreement Name: COSCO/ONE/
OOCL/YM EMED–USEC Vessel Sharing
Agreement.
Parties: COSCO SHIPPING Lines Co.,
Ltd.; Ocean Network Express Pte. Ltd.;
Orient Overseas Container Line Limited;
and Yang Ming Marine Transport Corp.,
Yang Ming (UK) Ltd., and Yang Ming
(Singapore) Pte. Ltd. (acting as a single
party).
Filing Party: Joshua Stein; Cozen
O’Connor.
Synopsis: The Agreement authorizes
the parties to cooperate on the provision
of a service operating between the U.S.
East Coast and ports in the
Mediterranean.
Proposed Effective Date: 3/4/2020.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/27479.
Agreement No.: 012056–002.
Agreement Name: WWOcean/EUKOR
Joint Operating Agreement.
Parties: Wallenius Wilhelmsen Ocean
AS and EUKOR Car Carriers, Inc.
VerDate Sep<11>2014
16:37 Mar 10, 2020
Jkt 250001
[Docket No. FDA–2020–D–0420]
Providing Regulatory Submissions in
Alternate Electronic Format; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Alternate Electronic Format.’’ Under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), Congress granted FDA the
authority to implement the statutory
electronic submission requirements in
guidance. In response, FDA
implemented binding guidance
requiring that new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), certain drug
master files (DMFs), certain biologics
license applications (BLAs), and certain
investigational new drug applications
(INDs) be submitted to the Agency in
electronic common technical document
(eCTD) format. Recognizing that some
submissions are exempt from this
requirement and that waivers of the
requirement may be granted on a caseby-case basis, the Agency is issuing this
draft guidance to describe the alternate
electronic format sponsors or applicants
should use for submissions covered
under such exemptions and waivers.
DATES: Submit either electronic or
written comments on the draft guidance
by May 11, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
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You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–
2020–D–0420 for ‘‘Providing Regulatory
Submissions in Alternate Electronic
Format.’’ 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
E:\FR\FM\11MRN1.SGM
11MRN1
Agencies
[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Page 14202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05002]
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FEDERAL MARITIME COMMISSION
Notice of Agreements Filed
The Commission hereby gives notice of the filing of the following
agreements under the Shipping Act of 1984. Interested parties may
submit comments, relevant information, or documents regarding the
agreements to the Secretary by email at [email protected], or by mail,
Federal Maritime Commission, Washington, DC 20573. Comments will be
most helpful to the Commission if received within 12 days of the date
this notice appears in the Federal Register. Copies of agreements are
available through the Commission's website (www.fmc.gov) or by
contacting the Office of Agreements at (202)-523-5793 or
[email protected].
Agreement No.: 201334.
Agreement Name: COSCO/ONE/OOCL/YM EMED-USEC Vessel Sharing
Agreement.
Parties: COSCO SHIPPING Lines Co., Ltd.; Ocean Network Express Pte.
Ltd.; Orient Overseas Container Line Limited; and Yang Ming Marine
Transport Corp., Yang Ming (UK) Ltd., and Yang Ming (Singapore) Pte.
Ltd. (acting as a single party).
Filing Party: Joshua Stein; Cozen O'Connor.
Synopsis: The Agreement authorizes the parties to cooperate on the
provision of a service operating between the U.S. East Coast and ports
in the Mediterranean.
Proposed Effective Date: 3/4/2020.
Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/27479.
Agreement No.: 012056-002.
Agreement Name: WWOcean/EUKOR Joint Operating Agreement.
Parties: Wallenius Wilhelmsen Ocean AS and EUKOR Car Carriers, Inc.
Filing Party: Wayne Rohde; Cozen O'Connor.
Synopsis: This amendment revises Article 5.6(c) of the Agreement to
exclude tug services from the services for which the parties are
authorized to negotiate jointly.
Proposed Effective Date: 3/5/2020.
Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/2021.
Dated: March 6, 2020.
Rachel Dickon,
Secretary.
[FR Doc. 2020-05002 Filed 3-10-20; 8:45 am]
BILLING CODE 6731-AA-P