Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Notices 78137 

Supplemental Form to the Financial 

Status Report (SF–425) is used by ACL/ 

AoA for all grantees to obtain a more 

detailed understanding of how projects 

funded under Title III of the Older 

Americans Act (OAA) of 1965, as 

amended, are being administered, and 

to ensure compliance with legislative 

requirements, pertinent Federal 

regulations and other applicable 

instructions and guidelines issued by 

the ACL. The level of data detail 

necessary is not available through the 

SF–425 form. The Supplemental Form 

provides necessary details on nonfederal required match, administration 

expenditures, and Long Term Care 

Ombudsman expenditures. 

Comments in Response to the 60-Day 

Federal Register Notice 

ACL published a 60-day Federal 

Register Notice in the Federal Register 

soliciting public comments on this 

request. The 60-day FRN published on 

August 19, 2020, Volume 85, Number 

161, pages 51033–51034; ACL did not 

receive any public comments during the 

60-day FRN period. The proposed data 

collection tools are on the ACL website 

for review and public comment, please 

visit https://www.acl.gov/about-acl/ 

public-input. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: 56 State Units on Aging (SUA) 

respond semi-annually which have an 

average estimated burden of 2 hours per 

grantee for a total of 224 hours annually. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual burden 

hours 

Title III Supplemental Form to the Financial Status Report ............................ 56 2 2 224 

Total .......................................................................................................... 56 2 2 224 

Dated: November 27, 2020. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2020–26602 Filed 12–2–20; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2242] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

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 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

FDA is establishing a docket for public 

comment on this document. Consistent 

with FDA’s regulations, this notice is 

being published with less than 15 days 

prior to the date of the meeting based on 

a determination that convening a 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee as soon as possible is 

warranted. This Federal Register notice 

could not be published 15 days prior to 

the date of the meeting due to a recent 

submission by Moderna, Inc., of a 

request for Emergency Use 

Authorization (EUA) for an 

investigational vaccine to prevent 

Coronavirus Disease 2019 (COVID–19) 

and the need for prompt discussion of 

such submission, given the COVID–19 

pandemic. 

DATES: Meeting date: The meeting will 

be held on December 17, 2020, from 9 

a.m. Eastern Time to 6 p.m. Eastern 

Time. 

Comment due date: Submit either 

electronic or written comments on this 

public meeting by December 16, 2020. 

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. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. The online web conference 

meeting will be available at the 

following link on the day of the 

meeting: https://fda.yorkcast.com/ 

webcast/Play/5cf9198bcc0745769b39

c699850945911d. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2020–N–2242. 

The docket will close on December 16, 

2020. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of December 16, 2020. 

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 

December 11, 2020, will be provided to 

the committee. Comments received after 

December 11, 2020, and by December 

16, 2020, will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications, submissions, 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 


khammond on DSKJM1Z7X2PROD with NOTICES
78138 Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Notices 

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–N–2242 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: 

Prabhakara Atreya or Kathleen Hayes, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 240–506–4946 or 301– 

796–7864, respectively; CBERAdvisory

Committees@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 

Agency’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 joining 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 EUA of the Moderna, Inc., 

COVID–19 Vaccine for the prevention of 

COVID–19 in individuals 18 years and 

older. EUA authority allows FDA to 

help strengthen the nation’s public 

health protections against chemical, 

biological, radiological, nuclear (CBRN) 

threats by facilitating the availability 

and use of Medical Countermeasures 

(MCMs) needed during public health 

emergencies. Under section 564 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–3), FDA may allow 

unapproved medical products or 

unapproved uses of approved medical 

products to be used in an emergency to 

diagnose, treat, or prevent serious or 

life-threatening diseases or conditions 

caused by CBRN threat agents when 

certain statutory criteria have been met, 

including that there are no adequate, 

approved, and available alternatives. 

Additional information about EUAs can 

be found at https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. 

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, 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/ 

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. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

December 11, 2020, will be provided to 

the committee. Comments received after 

December 11, 2020, and by December 

16, 2020, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 12 

p.m. Eastern Time 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 December 9, 2020. 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 

December 10, 2020. 

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 Prabhakara 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Notices 78139 

Atreya or Kathleen Hayes (CBER

AdvisoryCommittees@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: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26704 Filed 12–1–20; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Infectious Diseases and 

Microbiology. 

Date: December 10, 2020. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Alexander D. Politis, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3210, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1150, politisa@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: November 30, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–26606 Filed 12–2–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Aging. The meeting will be 

open to the public as indicated below, 

with a short public comment period at 

the end. The open session will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov). 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council on Aging. 

Date: January 12–13, 2021. 

Closed: January 12, 2021, 3:00 p.m. to 5:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Open: January 13, 2021, 10:00 a.m. to 1:30 

p.m. 

Agenda: Call to order and report from the 

Director; Discussion of future meeting dates; 

Consideration of minutes of last meeting; 

Reports from Task Force on Minority Aging 

Research, Working Group on Program; 

Council Speaker; Program Highlights. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Closed: January 13, 2021, 1:30 p.m. to 2:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kenneth Santora, Ph.D., 

Director, Office of Extramural Activities, 

National Institute on Aging, National 

Institutes of Health, Gateway Building, 7201 

Wisconsin Avenue, Bethesda, MD 20814, 

(301) 496–9322, ksantora@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nia.nih.gov/about/naca, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: November 30, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–26607 Filed 12–2–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[1651–0003] 

Agency Information Collection 

Activities: Transportation Entry and 

Manifest of Goods Subject to CBP 

Inspection and Permit 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 30-day notice and request for 

comments; extension of an existing 

collection of information. 

SUMMARY: The Department of Homeland 

Security, U.S. Customs and Border 

Protection will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995 (PRA). The 

information collection is published in 

the Federal Register to obtain comments 

from the public and affected agencies. 

DATES: Comments are encouraged and 

must be submitted (no later than 

January 4, 2021) to be assured of 

consideration. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 


khammond on DSKJM1Z7X2PROD with NOTICES