9506 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

1See 70 FR 15736 (March 29, 2005). 

2 15 U.S.C. 6801(b). 

3See SR 18–5/CA 18–7: Interagency Statement 

Clarifying the Role of Supervisory Guidance (Sept. 

11, 2018). 

4 5 U.S.C. 552(b)(4). 

Board of Governors of the Federal Reserve 

System, February 10, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–03048 Filed 2–12–21; 8:45 am] 

BILLING CODE P 

FEDERAL RESERVE SYSTEM 

Agency Information Collection 

Activities: Announcement of Board 

Approval Under Delegated Authority 

and Submission to OMB 

AGENCY: Board of Governors of the 

Federal Reserve System. 

SUMMARY: The Board of Governors of the 

Federal Reserve System (Board) is 

adopting a proposal to extend for three 

years, without revision the Reporting, 

Recordkeeping, and Disclosure 

Provisions Associated with the 

Guidance on Response Programs for 

Unauthorized Access to Customer 

Information and Customer Notice (FR 

4100; OMB No. 7100–0309). 

FOR FURTHER INFORMATION CONTACT: 

Federal Reserve Board Clearance 

Officer—Nuha Elmaghrabi—Office of 

the Chief Data Officer, Board of 

Governors of the Federal Reserve 

System, Washington, DC 20551, (202) 

452–3829. Office of Management and 

Budget (OMB) Desk Officer—Shagufta 

Ahmed—Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, New 

Executive Office Building, Room 10235, 

725 17th Street NW, Washington, DC 

20503, or by fax to (202) 395–6974. 

SUPPLEMENTARY INFORMATION: On June 

15, 1984, OMB delegated to the Board 

authority under the PRA to approve and 

assign OMB control numbers to 

collections of information conducted or 

sponsored by the Board. Boardapproved collections of information are 

incorporated into the official OMB 

inventory of currently approved 

collections of information. The OMB 

inventory, as well as copies of the PRA 

Submission, supporting statements, and 

approved collection of information 

instrument(s) are available at https://

www.reginfo.gov/public/do/PRAMain. 

These documents are also available on 

the Federal Reserve Board’s public 

website at https://

www.federalreserve.gov/apps/ 

reportforms/review.aspx or may be 

requested from the agency clearance 

officer, whose name appears above. 

Final Approval Under OMB Delegated 

Authority of the Extension for Three 

Years, Without Revision, of the 

Following Information Collection 

Report title: Reporting, 

Recordkeeping, and Disclosure 

Provisions Associated with the 

Guidance on Response Programs for 

Unauthorized Access to Customer 

Information and Customer Notice. 

Agency form number: FR 4100. 

OMB control number: 7100–0309. 

Frequency: On occasion. 

Respondents: State member banks, 

bank holding companies (BHCs), 

affiliates and certain non-banking 

subsidiaries of BHCs, uninsured state 

agencies and branches of foreign banks, 

commercial lending companies owned 

or controlled by foreign banks, savings 

and loan holding companies, and Edge 

and agreement corporations. 

Estimated number of respondents: 

Recordkeeping, 1; Reporting, 831; 

Disclosure, 831. 

Estimated average hours per response: 

Recordkeeping, 24 hours; Reporting, 9 

hours; Disclosure, 27 hours. 

Estimated annual burden hours: 

Recordkeeping, 24 hours; Reporting, 

7,479 hours; Disclosure, 22,437 hours. 

General description of report: The FR 

4100 is the Board’s information 

collection associated with the 

Interagency Guidance on Response 

Programs for Unauthorized Access to 

Customer Information and Customer 

Notice (‘‘ID-Theft Guidance’’ or 

‘‘Guidance’’). The ID-Theft Guidance 

was published in the Federal Register 

in March 2005.1 The ID-Theft Guidance, 

which applies to financial institutions, 

was issued in response to developing 

trends in the theft and accompanying 

misuse of customer information. The 

Guidance includes certain voluntary 

reporting, recordkeeping, and disclosure 

provisions. 

Legal authorization and 

confidentiality: The FR 4100 is 

authorized by section 501(b) of the 

Gramm-Leach-Bliley Act,2 which 

requires the Board, the Federal Deposit 

Insurance Corporation, and the Office of 

the Comptroller of the Currency to 

establish appropriate standards for 

financial institutions to develop and 

implement an information security 

program designed to protect their 

customers’ information and a response 

program that specifies actions to be 

taken when the institution suspects or 

detects that unauthorized individuals 

have gained access to customer 

information systems. 

Because the provisions under the FR 

4100 are contained in guidance, which 

is nonbinding, the provisions are 

voluntary.3

The disclosure provisions of FR 4100 

are not confidential. The records 

maintained under recordkeeping 

provisions of FR 4100 would be 

maintained at each banking 

organization, and the Freedom of 

Information Act (‘‘FOIA’’) would only 

be implicated if the Board obtained such 

records as part of the examination or 

supervision of a banking organization. 

In the event the records are obtained by 

the Board as part of an examination or 

supervision of a financial institution, 

this information may be considered 

confidential pursuant to exemption 8 of 

the FOIA, which protects information 

contained in ‘‘examination, operating, 

or condition reports’’ obtained in the 

bank supervisory process. In addition, 

the information obtained by the Board 

under the FR 4100 may also be kept 

confidential under exemption 4 for the 

FOIA, which protects commercial or 

financial information obtained from a 

person that is privileged or 

confidential.4

Current actions: On October 14, 2020, 

the Board published a notice in the 

Federal Register (85 FR 65046) 

requesting public comment for 60 days 

on the extension, without revision, of 

the Reporting, Recordkeeping, and 

Disclosure Provisions Associated with 

the Guidance on Response Programs for 

Unauthorized Access to Customer 

Information and Customer Notice. The 

comment period for this notice expired 

on December 14, 2020. The Board did 

not receive any comments. 

Board of Governors of the Federal Reserve 

System, February 10, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–03072 Filed 2–12–21; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0089] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9507 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee. The general function of the 

committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

March 5, 2021, from 9 a.m. Eastern Time 

to 3:30 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/dG_

NjxSYBkA. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0089. 

The docket will close on March 4, 2021. 

Submit either electronic or written 

comments on this public meeting by 

March 4, 2021. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 24, 

2021, to be provided to the committee. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 4, 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. 

Comments received on or before 

February 24, 2021, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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– 

2021–N–0089 for ‘‘Vaccines and Related 

Biological Products; Notice of Meeting; 

Establishment of a Public Docket; 

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.’’ FDA 

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 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 the 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: 

Kathleen Hayes or Monique Hill, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6306, Silver Spring, MD 20993–0002, 

301–796–7864 or 301–796–4620, 

respectively; CBERVRBPAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

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

advisory-committees 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 meet in open session to 

discuss and make recommendations on 

the selection of strains to be included in 

the influenza virus vaccines for the 2021 

to 2022 influenza season. 

FDA intends to make background 

material available to the public no later 


khammond on DSKJM1Z7X2PROD with NOTICES
9508 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

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 at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

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

advisory-committees/advisorycommittee-calendar. 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. Written 

submissions made to the Docket (see 

ADDRESSES) on or before February 24, 

2021, will be provided to the committee. 

Comments received after February 24, 

2021, and by March 4, 2021, will be 

taken into consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. Eastern Time and 2:30 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 February 18, 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 

February 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 Kathleen 

Hayes, CBERVRBPAC@fda.hhs.gov, 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/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings 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: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03014 Filed 2–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–5364] 

Submission of Plans for Cigarette 

Packages and Cigarette 

Advertisements (Revised); 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 revised 

guidance for industry entitled 

‘‘Submission of Plans for Cigarette 

Packages and Cigarette Advertisements 

(Revised).’’ This is a revision to the 

second edition of this final guidance, 

which issued in May 2020, and is 

intended to assist those required to 

submit cigarette plans for cigarette 

packages and cigarette advertisements 

by providing content, timing, and other 

recommendations related to those 

submissions. FDA is revising this 

guidance to reflect the December 2, 

2020, court order that postponed the 

effective date of the final rule entitled 

‘‘Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements’’ to January 14, 2022. 

Pursuant to the court order, this revised 

guidance strongly encourages entities to 

submit cigarette plans to FDA as soon as 

possible after publication of the final 

rule, and in any event, by March 16, 

2021. 

DATES: The announcement of the 

revised guidance is published in the 

Federal Register on February 16, 2021. 

ADDRESSES: You may submit 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– 

2019–D–5364 for ‘‘Submission of Plans 

for Cigarette Packages and Cigarette 

Advertisements (Revised).’’ 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 

office 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 


khammond on DSKJM1Z7X2PROD with NOTICES