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Allergen: Draft Guidance for Industry; 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draft guidance entitled ‘‘Voluntary 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Draft Guidance for Industry,’’ which 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
84348 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

‘‘Voluntary Disclosure of Sesame as an 

Allergen: Draft Guidance for Industry; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request.’’ This 

action opened a docket with a 60-day 

comment period to receive comments 

related to the voluntary disclosure of 

sesame as an allergen. 

We have received a request for a 60- 

day extension of the comment period for 

the draft guidance. The request 

conveyed concern that the current 60- 

day comment period does not allow 

sufficient time to develop a meaningful 

response to the draft guidance. In the 

interest of balancing the public health 

importance of sesame allergen labeling 

and granting additional time to submit 

comments before we finalize the draft 

guidance, we have concluded that it is 

reasonable to extend the comment 

period for 45 days, until February 25, 

2021. We believe that this extension 

allows adequate time for interested 

persons to submit comments. 

Dated: December 18, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28559 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–2017–D–4303] 

Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling; 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 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling.’’ This guidance is being issued 

in accordance with the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), which amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to require that certain 

submissions under the FD&C Act and 

the Public Health Service Act (PHS Act) 

be submitted in electronic format, 

beginning no earlier than 24 months 

after issuance of final guidance on 

electronic format for submissions. The 

guidance describes how FDA plans to 

implement the requirements for the 

electronic submission of Risk 

Evaluation and Mitigation Strategies 

(REMS) documents in certain 

submissions under new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and certain 

biologics license applications (BLAs), 

beginning December 28, 2022. This 

guidance finalizes the draft guidance 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Content of the Risk Evaluation and 

Mitigation Strategies Document Using 

Structured Product Labeling’’ published 

September 5, 2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 28, 2020. 

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 

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– 

2017–D–4303 for ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Content of the Risk Evaluation and 

Mitigation Strategies Document Using 

Structured Product Labeling.’’ 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.gpo.gov/ 

fdsys/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)). 


tkelley on DSKBCP9HB2PROD with NOTICES