Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84345 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will discuss supplemental 

biologics license application (sBLA) 

125514/s–089, for KEYTRUDA 

(pembrolizumab), submitted by Merck 

Sharp & Dohme Corp., a subsidiary of 

Merck & Co., Inc. The proposed 

indication (use) for this product is for 

the treatment of patients with high-risk, 

early-stage triple-negative breast cancer, 

in combination with chemotherapy as 

neoadjuvant treatment, then as a single 

agent as adjuvant treatment after 

surgery. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

January 26, 2021, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 12 noon and 1 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before January 

15, 2021. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by January 19, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact She-Chia Chen 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 18, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28558 Filed 12–23–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2252] 

Interim Assessment of the Program for 

Enhanced Review Transparency and 

Communication in the Biosimilar User 

Fee Act; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Interim Assessment of 

the Program for Enhanced Review 

Transparency and Communication in 

the Biosimilar User Fee Act (BsUFA)’’ 

and an opportunity for public comment. 

The topics to be discussed are the 

interim assessment and public 

stakeholder views of the program to 

date. 

DATES: The public meeting will be held 

on January 27, 2021, from 9:30 a.m. to 

12:30 p.m. Eastern Time and will take 

place virtually by Adobe Connect only. 

Submit either electronic or written 

comments on this public meeting by 

March 29, 2021. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

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 March 29, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of March 29, 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. 


tkelley on DSKBCP9HB2PROD with NOTICES
84346 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

• 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–N–2252 for ‘‘Interim Assessment 

of the Program for Enhanced Review 

Transparency and Communication in 

the Biosimilar User Fee Act (BsUFA); 

Public Meeting; Request for Comments.’’ 

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: 

Kimberly Taylor, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1152, 

Silver Spring, MD 20993, 240–402– 

5193, Kimberly.taylor@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The BsUFA was originally enacted in 

2012 as the Biosimilar User Fee Act 

under the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) for a period of 5 

years. In 2017, the BsUFA was renewed 

for 5 more years under the FDA 

Reauthorization Act of 2017 (FDARA) 

(BsUFA II) (Pub. L. 115–52, Title IV)). 

The BsUFA’s intent is to provide 

additional revenues so that FDA can 

hire staff, improve systems, and 

continue a well-managed biosimilar 

biological product review process to 

make biosimilar biological product 

therapies available to patients sooner. 

BsUFA II was authorized to continue 

the collection of user fees by FDA to 

facilitate and expedite the process for 

the review of biosimilar biological 

products in the United States. 

Under BsUFA II, FDA committed to 

apply a new review model to original 

biosimilar biologics license application 

(BLA) reviews. That review model is 

identified in section II.B. of the BsUFA 

II Commitment Letter as the Program for 

Enhanced Review Transparency and 

Communication for Original 351(k) 

BLAs (the Program). The Program 

provides opportunities for increased 

communication between FDA and 

applicants, including mid-cycle and 

late-cycle meetings. To accommodate 

the increased interaction during 

regulatory review, FDA’s review clock 

begins after the 60-day administrative 

filing review period for applications 

reviewed under the Program. The goal 

of the Program is to promote the 

efficiency and effectiveness of the firstcycle review process and minimize the 

number of review cycles necessary for 

approval, ensuring that patients have 

timely access to safe, effective, and high 

quality biosimilar and interchangeable 

biological products. 

An independent evaluator is assessing 

the Program to understand its effect on 

the review of BsUFA applications. In 

addition to publishing an interim 

assessment on FDA’s website, a public 

meeting will be held on January 27, 

2021, where the interim assessment will 

be discussed, and public stakeholders 

may present their views on the Program 

to date. 

Additional information concerning 

the BsUFA—including the text of the 

law, the ‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 through 

2022’’ (the BsUFA II Commitment 

Letter), ‘‘Biosimilar Authorization 

Performance Goals and Procedures 

Fiscal Years 2013 through 2017’’ (the 

BsUFA Commitment Letter), key 

Federal Register documents, BsUFArelated guidances, BsUFA user fee rates, 

performance reports, and financial 

reports—may be found at https://

www.fda.gov/industry/fda-user-feeprograms/biosimilar-user-feeamendments. 

II. Topics for Discussion at the Public 

Meeting 

FDA and an independent contractor 

will discuss the findings of the interim 

assessment, including anonymized and 

aggregated feedback from biosimilar 

BLA applicants and FDA review teams 

resulting from independent contractor 

interviews. FDA will discuss any issues 

identified to date, including any 

proposed plans to improve the 

likelihood of the Program’s success. A 

panel of external stakeholders will also 

provide their perspective. To view the 

interim assessment report, please visit 

here: https://www.fda.gov/industry/ 

biosimilar-user-fee-amendments/bsufaii-assessment-program-enhancedreview-transparency-andcommunication-biosimilar-user-fee-act. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website to register: https://

www.eventbrite.com/e/public-meetingon-the-interim-assessment-of-the-bsufaii-program-tickets-127577568943. Please 

provide complete contact information 

for each attendee, including name, 

affiliation, and email. 

Persons interested in attending this 

public meeting must register by January 

26, 2021, at 11:59 p.m. Eastern Time. 

Registrants will receive confirmation 

once they have been accepted. 

Requests for Oral Presentations: 

Those who register online by January 

14, 2021, will receive a notification 

about an opportunity to participate in 

the public comment session of the 

meeting. If you wish to speak during the 

public comment session, follow the 

instructions in the notification and 

identify 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 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84347 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

January 15, 2021, 11:59 p.m. Eastern 

Time. We will determine the amount of 

time allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by January 20, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

held via Adobe Connect. The link for 

this public meeting is https://

collaboration.fda.gov/bsufa012721. 

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 

meeting 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 at 

www.regulations.gov in this docket. 

Dated: December 21, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28602 Filed 12–23–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–0530] 

Voluntary Disclosure of Sesame as an 

Allergen: Draft Guidance for Industry; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

draft guidance entitled ‘‘Voluntary 

Disclosure of Sesame as an Allergen: 

Draft Guidance for Industry,’’ which 

was announced in the Federal Register 

of November 12, 2020. We are taking 

this action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance published 

November 12, 2020 (85 FR 71920). 

Submit either electronic or written 

comments on the draft guidance by 

February 25, 2021, to ensure that we 

consider your comment on the draft 

guidance before we begin 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– 

2020–D–0530 for ‘‘Voluntary Disclosure 

of Sesame as an Allergen: Draft 

Guidance for Industry; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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: 

Carol D’lima, Office of Nutrition and 

Food Labeling, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2371. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 12, 2020 

(85 FR 71920), we published a notice of 

availability for a draft guidance entitled 


tkelley on DSKBCP9HB2PROD with NOTICES