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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
FEDERAL ELECTION COMMISSION
Sunshine Act Meeting Tuesday, September 14, 2021 at 10:00 a.m.
PLACE: 1050 First Street NE, Washington, DC this meeting will be a virtual meeting.
STATUS: This meeting will be closed to the public.
MATTERS TO BE CONSIDERED:
Compliance matters pursuant to 52
U.S.C. 30109.
Matters relating to internal personnel decisions, or internal rules and practices.
Investigatory records compiled for law enforcement purposes and production would disclose investigative techniques.
Matters concerning participation in civil actions or proceedings or arbitration.

CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer; Telephone:
202 6941220.
TIME AND DATE:

Vicktoria J. Allen, Acting Deputy Secretary of the Commission.
FR Doc. 202119597 Filed 9721; 4:15 pm
also revise the agreement to replace references to NYK with ONE and delete provisions of the agreement relating to the now complete transition to ONE.
The parties request expedited review.
Proposed Effective Date: 10/16/2021.
Location: https www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/1972.
Dated: September 3, 2021.
Rachel E. Dickon, Secretary.
FR Doc. 202119483 Filed 9821; 8:45 am BILLING CODE 673002P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D0875

S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

BILLING CODE 671501P

Notice of availability.

The Food and Drug Administration FDA or Agency is announcing the availability of a draft guidance for industry entitled S12
Nonclinical Biodistribution Considerations for Gene Therapy Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation ICH, formerly the International Conference on Harmonisation. The draft guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution BD studies for gene therapy GT products. Considerations for interpretation and application of the BD data to support a nonclinical development program and inform the design of clinical trials are also provided. The recommendations in the guidance endeavour to facilitate the development of investigational GT
products, while avoiding unnecessary use of animals, in accordance with the 3Rs reduce/refine/replace principles.
The draft guidance is intended to promote harmonization of recommendations for BD studies for investigational GT products and facilitate a more efficient and timely nonclinical development program.
DATES: Submit either electronic or written comments on the draft guidance by November 8, 2021 to ensure that the Agency considers your comment on this SUMMARY:

FEDERAL MARITIME COMMISSION

lotter on DSK11XQN23PROD with NOTICES1

Notice of Agreement Filed The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984.
Interested parties may submit comments, relevant information, or documents regarding the agreement 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 agreement are available through the Commissions website www.fmc.gov or by contacting the Office of Agreements at 202523
5793 or tradeanalysis@fmc.gov.
Agreement No.: 012474002.
Agreement Name: ONE/ELJSA Space Charter Agreement.
Parties: Ocean Network Express Pte.
Ltd.; and Evergreen Line Joint Service Agreement.
Filing Party: Joshua Stein; Cozen OConnor.
Synopsis: The amendment would revise the agreement to reduce the total amount of space that will be provided by ONE to ELJSA and change the service that such space will be provided on to the FP1 service. The amendment would
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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 elses 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 HFA305, 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
2021D0875 for S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. Received comments will be placed in the docket and, except for those submitted as Confidential Submissions, are publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper
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