33312 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

thinking of FDA on ‘‘Chemistry, 

Manufacturing, and Controls Changes to 

an Approved Application: Certain 

Biological 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 

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 210 and 21 

CFR part 211 have been approved under 

OMB control number 0910–0139; the 

collections of information in 21 CFR 

601.12 have been approved under OMB 

control numbers 0910–0338, and the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 15, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13392 Filed 6–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0512] 

Considerations for Progressive 

Multifocal Leukoencephalopathy 

Clinical Trial Designs; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the following public 

workshop entitled ‘‘Considerations for 

Progressive Multifocal 

Leukoencephalopathy Clinical Trial 

Designs.’’ The purpose of the public 

workshop is to discuss the challenges 

and clinical trial design considerations 

for developing therapeutic products for 

the treatment of progressive multifocal 

leukoencephalopathy (PML). 

DATES: The public workshop will be 

held virtually on September 21, 2021, 

from 10 a.m. to 4:15 p.m., Eastern Time. 

Submit either electronic or written 

comments on this public workshop by 

November 1, 2021. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held in virtual format only. 

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 November 1, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of November 1, 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–0512 for ‘‘Considerations for 

Progressive Multifocal 

Leukoencephalopathy Clinical Trial 

Designs.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33313 

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: Lori 

Benner and/or Antoinette Ziolkowski, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6221, Silver Spring, 

MD 20993–0002, 301–796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Progressive Multifocal 

Leukoencephalopathy (PML) is a rare, 

often fatal viral disease of the central 

nervous system that affects patients 

with immunosuppressive conditions 

and those treated with 

immunomodulatory agents. No products 

are approved for the treatment of PML 

and no therapeutic development 

pathway is established for PML. FDA 

seeks to discuss scientific and 

regulatory challenges associated with 

designing clinical trials evaluating PML 

treatments, and to develop PML clinical 

trial designs that are feasible, adequate 

to establish substantial evidence of 

effectiveness, adequate to characterize 

the safety profile of investigational 

treatments, and acceptable to PML 

patients, clinicians, regulators, and 

industry. 

The Agency encourages healthcare 

providers, employees of other U.S. 

Government agencies, academic experts, 

industry experts, patients and patient 

advocates, and other stakeholders to 

attend this public workshop. 

II. Topics for Discussion at the Public 

Workshop 

Discussions are planned around the 

following topics areas: 

• Unmet need for PML therapeutics. 

• Key trial design considerations, 

including feasibility, trial populations, 

selection of control groups, endpoints, 

adaptive designs, and master protocols. 

III. Participating in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online by September 20, 2021, 

midnight Eastern Time using the 

weblink for this workshop noted in the 

Transcripts section below. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Requests for Oral Presentations: 

During online registration, you may 

indicate if you wish to present during 

the virtual public comment session and 

which topic(s) you wish to address. We 

will do our best to accommodate 

requests to make public comments. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. We will 

determine the amount of time allotted to 

each presenter and the approximate 

time each oral presentation is to begin, 

and will select and notify participants 

by September 10, 2021. All requests to 

make oral presentations must be 

received by September 3, 2021. If 

selected for presentation, any 

presentation materials must be emailed 

to the ONDPublicMTGSupport@

fda.hhs.gov no later than September 16, 

2021. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming webcast of the public 

workshop: This public workshop will be 

webcast at the following site: https://

collaboration.fda.gov/fdawork

shop092121. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/drugs/news-eventshuman-drugs/considerationsprogressive-multifocalleukoencephalopathy-clinical-trialdesigns-09212021-09212021. 

Dated: June 15, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13371 Filed 6–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1553] 

Premenopausal Women With Breast 

Cancer: Developing Drugs for 

Treatment; 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 final 

guidance for industry entitled 

‘‘Premenopausal Women with Breast 

Cancer: Developing Drugs for 

Treatment.’’ This guidance provides 

recommendations regarding the 

inclusion of premenopausal women in 

breast cancer clinical trials. The 

guidance is intended to assist 

stakeholders, including sponsors and 

institutional review boards, responsible 

for the development and oversight of 

clinical trials for breast cancer drugs. 

This guidance finalizes the draft 

guidance of the same title issued on 

October 8, 2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 24, 2021. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES