Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 47645 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

MS H24–8, Atlanta, Georgia 30329– 

4027, Attn: August 30–31, 2021 ACIP 

Meeting. 

Instructions: All submissions received 

must include the Agency name and 

Docket Number. All relevant comments 

received in conformance with the 

https://www.regulations.gov suitability 

policy will be posted without change to 

https://www.regulations.gov, including 

any personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Thomas, ACIP Committee 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road 

NE, MS–H24–8, Atlanta, GA 30329– 

4027; Telephone: 404–639–8367; Email: 

ACIP@cdc.gov. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given of a change in the meeting 

of the Advisory Committee on 

Immunization Practices (ACIP); August 

24, 2021, 10:00 a.m.–5:00 p.m., EDT 

(times subject to change), in the original 

FRN. 

The virtual meeting was published in 

the Federal Register on Wednesday, 

August 18, 2021, Volume 86, Number 

157, pages 46256–46257. 

The virtual meeting is being amended 

to change the dates to August 30, 2021 

and August 31, 2021, update meeting 

times and supplemental information. 

In accordance with 41 CFR 102– 

3.150(b), less than 15 calendar days’ 

notice is being given for this meeting 

due to the exceptional circumstances of 

the COVID–19 pandemic and rapidly 

evolving COVID–19 vaccine 

development and regulatory processes. 

A notice of this ACIP meeting has also 

been posted on CDC’s ACIP website at: 

http://www.cdc.gov/vaccines/acip/ 

index.html. In addition, CDC has sent 

notice of this ACIP meeting by email to 

those who subscribe to receive email 

updates about ACIP. 

Purpose: The committee is charged 

with advising the Director, CDC, on the 

use of immunizing agents. In addition, 

under 42 U.S.C. 1396s, the committee is 

mandated to establish and periodically 

review and, as appropriate, revise the 

list of vaccines for administration to 

vaccine-eligible children through the 

Vaccines for Children (VFC) program, 

along with schedules regarding dosing 

interval, dosage, and contraindications 

to administration of vaccines. Further, 

under provisions of the Affordable Care 

Act, section 2713 of the Public Health 

Service Act, immunization 

recommendations of the ACIP that have 

been approved by the Director of the 

Centers for Disease Control and 

Prevention and appear on CDC 

immunization schedules must be 

covered by applicable health plans. 

Matters To Be Considered: The agenda 

will include discussions on Pfizer’s 

COVID–19 vaccine, and additional 

discussions on mRNA booster doses. A 

recommendation vote on Pfizer’s 

COVID–19 vaccine is planned. No 

Vaccines for Children (VFC) votes are 

scheduled. Agenda items are subject to 

change as priorities dictate. For more 

information on the meeting agenda visit 

https://www.cdc.gov/vaccines/acip/ 

meetings/meetings-info.html. 

Meeting Information: The meeting 

will be webcast live via the World Wide 

Web; for more information on ACIP 

please visit the ACIP website: http://

www.cdc.gov/vaccines/acip/index.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials, are part of 

the public record and are subject to 

public disclosure. Comments will be 

posted on https://www.regulations.gov. 

Therefore, do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

Oral Public Comment: This meeting 

will include time for members of the 

public to make an oral comment. Oral 

public comment will occur before any 

scheduled votes including all votes 

relevant to the ACIP’s Affordable Care 

Act and Vaccines for Children Program 

roles. Priority will be given to 

individuals who submit a request to 

make an oral public comment before the 

meeting according to the procedures 

below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the August 30, 2021, 

ACIP meeting must submit a request at 

http://www.cdc.gov/vaccines/acip/ 

meetings/ no later than 11:59 p.m., EDT, 

August 28, 2021, according to the 

instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by August 29, 2021. To accommodate 

the significant interest in participation 

in the oral public comment session of 

ACIP meetings, each speaker will be 

limited to 3 minutes, and each speaker 

may only speak once per meeting. 

Written Public Comment: The docket 

is currently open to receive written 

comments. Written comments must be 

received on or before August 31, 2021. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–18453 Filed 8–24–21; 11:15 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the General and Plastic 

Surgery Devices Panel of the Medical 

Devices 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. 


jbell on DSKJLSW7X2PROD with NOTICES
47646 Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 

DATES: The meeting will take place 

virtually on October 20, 2021, from 9 

a.m. Eastern Time to 6 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. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability may 

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

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Candace Nalls, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5216, Silver Spring, 

MD 20993–0002, candace.nalls@

fda.hhs.gov, 301–636–0510, 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/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 the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On October 

20, 2021, the committee will discuss, 

make recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

SurgiMend PRS Acellular Bovine 

Dermal Matrix (SurgiMend PRS ABDM) 

by Integra LifeSciences Corporation. 

The proposed Indication for Use, as 

stated in the PMA, is as follows: 

SurgiMend PRS Acellular Bovine 

Dermal Matrix is intended for use as soft 

tissue support in post-mastectomy 

breast reconstruction. SurgiMend PRS 

Acellular Bovine Dermal Matrix is 

specifically indicated for immediate, 

two-stage, submuscular, alloplastic 

breast reconstruction. 

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, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

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

advisory-committees/medical-devicesadvisory-committee/general-and-plasticsurgery-devices-panel. Select the link 

for the 2021 Meeting Materials. 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 may be made to the contact 

person on or before October 6, 2021. 

Oral presentations from the public will 

be scheduled on October 20, 2021, 

between approximately 2 p.m. Eastern 

Time and 3 p.m. Eastern Time. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person (see FOR FURTHER

INFORMATION CONTACT). The notification 

should include 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 

September 28, 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 sessions. The contact person 

will notify interested persons regarding 

their request to speak by September 29, 

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 Ann Marie 

Williams at annmarie.williams@

fda.hhs.gov or 301–796–5966 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: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18394 Filed 8–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0806] 

Advisory Committee; Nonprescription 

Drugs Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the renewal of the 

Nonprescription Drugs 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 

Nonprescription Drugs Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

August 27, 2023, expiration date. 

DATES: Authority for the 

Nonprescription Drugs Advisory 

Committee will expire on August 27, 

2021, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Moon Hee V. Choi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301 

837–7126, NDAC@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 

Nonprescription Drugs 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 


jbell on DSKJLSW7X2PROD with NOTICES