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Allergen: Draft Guidance for Industry; 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the draft guidance.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response to the draft guidance.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
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84349 

Submit written requests for single 

copies of this guidance 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; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

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: 

Nancy Guan, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–348–1549; or Stephen Ripley, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling.’’ FDASIA amended the FD&C 

Act to require that certain submissions 

under the FD&C Act and the PHS Act be 

submitted in electronic format, 

beginning no earlier than 24 months 

after issuance of final guidance on 

electronic format for submissions. This 

guidance describes how FDA plans to 

implement the requirements for the 

electronic submission of REMS 

documents in certain submissions under 

NDAs, ANDAs, and certain 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’’ issued 

September 5, 2017 (82 FR 41968). FDA 

has considered all the public comments 

received on the draft guidance in 

finalizing this guidance. FDA made 

editorial changes to improve clarity and 

address comments as appropriate. FDA 

also amended language in Part III.C of 

the guidance to reflect the recent 

publication of exemption and waiver 

criteria for eCTD submissions in a 

separate guidance. 

FDA guidances ordinarily contain 

standard language explaining that 

guidances should be viewed only as 

recommendations unless specific 

regulatory or statutory requirements are 

cited. FDA is not including this 

standard language in this guidance 

because this guidance contains binding 

provisions. In section 745A(a) of the 

FD&C Act, Congress granted explicit 

authorization to FDA to specify in 

guidance the format for the electronic 

submissions required under that 

section. Accordingly, this guidance 

explains such requirements under 

section 745A(a) of the FD&C Act, 

indicated by the use of the words must 

or required, and therefore is not subject 

to the usual restrictions in FDA’s good 

guidance practice regulations, such as 

the requirement that guidances not 

establish legally enforceable 

responsibilities. See 21 CFR 10.115(d). 

This guidance represents the Agency’s 

current thinking on ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Content of the Risk Evaluation 

and Mitigation Strategies Document 

Using Structured Product Labeling.’’ 

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 314 have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, https://www.fda.gov/

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: December 21, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28560 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–0008] 

Advisory Committee; Cellular, Tissue 

and Gene Therapies Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Cellular, Tissue and Gene 

Therapies Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Cellular, Tissue 

and Gene Therapies Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

October 28, 2022, expiration date. 

DATES: Authority for the Cellular, Tissue 

and Gene Therapies Advisory 

Committee will expire on October 28, 

2022, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Prabhakara Atreya, Division of 

Scientific Advisors and Consultants, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10993 New Hampshire 

Ave., Bldg. 71, Rm. 6306, Silver Spring, 

MD 20993–0002, 240–402–8006, 

Prabhakara.Atreya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Cellular, Tissue and Gene Therapies 

Advisory Committee (the Committee). 

The Committee is a discretionary 

Federal advisory committee established 

to provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies, and 

xenotransplantation products, which are 

intended for transplantation, 


tkelley on DSKBCP9HB2PROD with NOTICES