50536 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 

FEDERAL ELECTION COMMISSION 

Sunshine Act Meeting 

TIME AND DATE: 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) 694–1220. 

Vicktoria J. Allen, 

Acting Deputy Secretary of the Commission. 

[FR Doc. 2021–19597 Filed 9–7–21; 4:15 pm] 

BILLING CODE 6715–01–P 

FEDERAL MARITIME COMMISSION 

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 Commission’s 

website (www.fmc.gov) or by contacting 

the Office of Agreements at (202)–523– 

5793 or tradeanalysis@fmc.gov. 

Agreement No.: 012474–002. 

Agreement Name: ONE/ELJSA Space 

Charter Agreement. 

Parties: Ocean Network Express Pte. 

Ltd.; and Evergreen Line Joint Service 

Agreement. 

Filing Party: Joshua Stein; Cozen 

O’Connor. 

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 

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. 2021–19483 Filed 9–8–21; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0875] 

S12 Nonclinical Biodistribution 

Considerations for Gene Therapy 

Products; International Council for 

Harmonisation; Draft Guidance for 

Industry; 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 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 

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– 

2021–D–0875 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, 240–402–7500. 

• 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 50537 

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.govinfo.gov/content/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, 240–402–7500. 

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 draft guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002, or 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. The draft guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 240–402– 

8010. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: 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: Jill Adleberg, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6364, Silver Spring, 

MD 20993–0002, 301–796–5259, 

Jill.Adleberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 ICH. ICH 

has the mission of achieving greater 

regulatory harmonization worldwide to 

ensure that safe, effective, high-quality 

medicines are developed, registered, 

and maintained in the most resourceefficient manner. 

By harmonizing the regulatory 

requirements in regions around the 

world, ICH guidelines have 

substantially reduced duplicative 

clinical studies, prevented unnecessary 

animal studies, standardized the 

reporting of important safety 

information, standardized marketing 

application submissions, and made 

many other improvements in the quality 

of global drug development and 

manufacturing and the products 

available to patients. 

The six Founding Members of the ICH 

are FDA; the Pharmaceutical Research 

and Manufacturers of America; the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labour, and Welfare; and the 

Japanese Pharmaceutical Manufacturers 

Association. The Standing Members of 

the ICH Association include Health 

Canada and Swissmedic. Additionally, 

the Membership of ICH has expanded to 

include other regulatory authorities and 

industry associations from around the 

world (refer to https://www.ich.org/). 

ICH works by involving technical 

experts from both regulators and 

industry parties in detailed technical 

harmonization work and the application 

of a science-based approach to 

harmonization through a consensusdriven process that results in the 

development of ICH guidelines. The 

regulators around the world are 

committed to consistently adopting 

these consensus-based guidelines, 

realizing the benefits for patients and for 

industry. 

As a Founding Regulatory Member of 

ICH, FDA plays a major role in the 

development of each of the ICH 

guidelines, which FDA then adopts and 

issues as guidance for industry. FDA’s 

guidance documents do not establish 

legally enforceable responsibilities. 

Instead, they describe the Agency’s 

current thinking on a topic and should 

be viewed only as recommendations, 

unless specific regulatory or statutory 

requirements are cited. 

In June 2021, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘S12 Nonclinical Biodistribution 

Considerations for Gene Therapy 

Products’’ and agreed that the guidance 

should be made available for public 

comment. The draft guidance is the 

product of the Safety Expert Working 

Group of the ICH. Comments about this 

draft guidance will be considered by 

FDA and the Safety Expert Working 

Group. 

FDA is thus announcing the 

availability of a draft guidance for 

industry entitled ‘‘S12 Nonclinical 

Biodistribution Considerations for Gene 

Therapy Products.’’ The draft guidance 

discusses the definition of BD and gives 

examples of GT products that are within 

the scope of the document. The 

guidance also provides 

recommendations for the design of 

nonclinical BD studies, such as the test 

article and dose level(s) administered, 

the animal species tested, route of 

administration, biofluid and tissue 

collection procedure, and other design 

elements. In addition, specific 

considerations, such as BD assay 

methods, GT expression product levels, 

and product immunogenicity are 

provided. The recommendations in the 

draft guidance are intended to promote 

harmonization in the development of a 

nonclinical development program for 

GT products to support clinical trial 

design, and reduce the use of animals, 

in accordance with the 3Rs (reduce/ 

refine/replace) principles. 

This draft guidance has been left in 

the original ICH format. The final 

guidance will be reformatted and edited 

to conform with FDA’s good guidance 

practices regulation (21 CFR 10.115) and 

style before publication. The draft 

guidance, when finalized, will represent 

the current thinking of FDA on ‘‘S12 

Nonclinical Biodistribution 

Considerations for Gene Therapy 

Products.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 


lotter on DSK11XQN23PROD with NOTICES1
50538 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001 and in 21 CFR part 

601 under OMB control number 0910– 

0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 

Dated: September 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19410 Filed 9–8–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0352] 

Intent To Prepare an Environmental 

Impact Statement for Certain 

Sunscreen Drug Products for Over-theCounter Use; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of intent; reopening of 

the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

reopening the comment period for 

public scoping on the environmental 

impact statement (EIS) described in the 

notice entitled ‘‘Intent To Prepare an 

Environmental Impact Statement for 

Certain Sunscreen Drug Products for 

Over-the-Counter Use’’ that appeared in 

the Federal Register of May 13, 2021. 

The Agency is taking this action to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is reopening the comment 

period for public scoping on the EIS 

identified in the notice published May 

13, 2021 (86 FR 26224). To ensure the 

Agency considers your comments on the 

draft EIS, submit either electronic or 

written comments on the scoping 

process discussed in the notice by 

September 23, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 23, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 23, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2021–N–0352 for ‘‘Intent To Prepare an 

Environmental Impact Statement for 

Certain Sunscreen Drug Products for 

Over-the-Counter Use.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Trang Q. Tran, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 


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