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 


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33314 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

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–1553 for ‘‘Premenopausal 

Women with Breast Cancer: Developing 

Drugs for Treatment.’’ 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, 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. 

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 guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research (CDER), Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Gao, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2135, Silver Spring, 

MD 20993, 240–402–4683; or Julia 

Beaver, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2100, Silver Spring, 

MD 20993, 240–402–0489; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Premenopausal Women with Breast 

Cancer: Developing Drugs for 

Treatment.’’ This guidance provides 

recommendations regarding the 

inclusion of premenopausal women, as 

defined by serum hormonal levels 

(including but not limited to folliclestimulating hormone and estradiol), in 

breast cancer clinical trials. The issues 

of fertility and fertility preservation 

when treating premenopausal women 

with breast cancer are outside the scope 

of this guidance. 

Historically, premenopausal women 

have been excluded from some trials 

that have investigated the efficacy of 

certain drugs that rely upon 

manipulation of the hormonal axis for 

the treatment of hormone receptor (HR) 

positive breast cancer. In some cases, 

separate studies have been conducted to 

confirm the benefit in this patient 

population. Certain groups of drugs, 

such as chemotherapy, immunotherapy, 

and targeted therapy (which act 

independent of the hormonal axis), have 

similar efficacy in pre- and 

postmenopausal women with breast 

cancer. Based on a review of the 

literature, FDA believes hormonal drugs 

administered to premenopausal women 

with HR-positive breast cancer, with 

adequate estrogen suppression, are 

likely to have the same efficacy and 

safety profile as in postmenopausal 

women. 

The guidance encourages sponsors to 

discuss their breast cancer drug 

development plan with CDER and 

CBER, as applicable, early in 

development. The guidance 

recommends that menopausal status 

should not be the basis for exclusion 

from breast cancer clinical trials. The 

guidance includes recommendations 

regarding eligibility criteria and study 

planning and design intended to 

facilitate the inclusion of 

premenopausal women in breast cancer 

clinical trials. 

This guidance finalizes the draft 

guidance entitled ‘‘Premenopausal 

Women with Breast Cancer: Developing 

Drugs for Treatment’’ issued on October 

8, 2020 (85 FR 63559). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include additional 

recommendations on the importance of 

clinical studies reflecting racial and 

ethnic diversity and to collect patient 

experience data throughout the 

development program. Other changes 

include updated recommendations on 

collection of clinical effects as part of 

the clinical development program or as 

part of a postmarketing requirement or 

commitment as applicable. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Premenopausal 

Women with Breast Cancer: Developing 

Drugs for Treatment.’’ 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 


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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33315 

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 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/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. 2021–13388 Filed 6–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

May 1, 2021, through May 31, 2021. 

This list provides the name of 

petitioner, city and state of vaccination 

(if unknown then city and state of 

person or attorney filing claim), and 

case number. In cases where the Court 

has redacted the name of a petitioner 

and/or the case number, the list reflects 

such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 

In accordance with Section 

2112(b)(2), all interested persons may 

submit written information relevant to 

the issues described above in the case of 

the petitions listed below. Any person 

choosing to do so should file an original 

and three (3) copies of the information 

with the Clerk of the United States 

Court of Federal Claims at the address 

listed above (under the heading ‘‘For 

Further Information Contact’’), with a 

copy to HRSA addressed to Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

5600 Fishers Lane, 08N146B, Rockville, 

Maryland 20857. The Court’s caption 

(Petitioner’s Name v. Secretary of HHS) 

and the docket number assigned to the 

petition should be used as the caption 

for the written submission. Chapter 35 

of title 44, United States Code, related 

to paperwork reduction, does not apply 

to information required for purposes of 

carrying out the Program. 

Diana Espinosa, 

Acting Administrator. 

List of Petitions Filed 

1. Kelly Hannon, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1304V 

2. Margaret Hoyt, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1305V 

3. Sarah Lopez, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1306V 

4. Lydia M. Goode, Greensboro, North 

Carolina, Court of Federal Claims No: 

21–1307V 

5. Jonathan Jarog, Chicago, Illinois, Court of 

Federal Claims No: 21–1308V 


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