52684 Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 

SUPPLEMENTARY INFORMATION: 

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 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 CDC Director and 

appear on CDC immunization schedules 

must be covered by applicable health 

plans. 

Matters To Be Considered: The agenda 

will include discussions on adult 

immunization schedule, child/ 

adolescent immunization schedule, 

Ebola vaccine, hepatitis vaccines, 

herpes zoster vaccines, Orthopoxviruses 

vaccine, influenza vaccines, 

pneumococcal vaccine, cholera vaccine 

and tickborne encephalitis vaccine. 

Recommendation votes on adult 

immunization schedule, child/ 

adolescent immunization schedule, 

hepatitis vaccine, herpes zoster vaccine, 

Orthopoxviruses vaccine, pneumococcal 

vaccine and Ebola vaccine are 

scheduled. No Vaccines for Children 

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/meetingsinfo.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. 

Written Public Comment: The docket 

will be opened to receive written 

comments on October 1, 2021. Written 

comments must be received on or before 

October 21, 2021. 

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 October 20–21, 

2021 ACIP meeting must submit a 

request at http://www.cdc.gov/vaccines/ 

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

EDT, October 18, 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 October 19, 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. 

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. 2021–20476 Filed 9–21–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0089] 

Advisory Committee on Immunization 

Practices (ACIP); Correction Notice of 

Meeting 

AGENCY: Centers for Disease Control and 

Prevention, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the Advisory 

Committee on Immunization Practices 

(ACIP). This meeting is open to the 

public. Time will be available for public 

comment. 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. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given of a change in the meeting 

of the Advisory Committee on 

Immunization Practices (ACIP); August 

30, 2021, 10:00 a.m. to 4:00 p.m., and 

August 31, 2021, 10:00 a.m. to 4:00 

p.m., EDT (times subject to change), in 

the amended FRN. 

The virtual meeting was published in 

the Federal Register on Thursday, 

August 26, 2021, Volume 86, Number 

163, pages 47644–47645. 

The virtual meeting is being corrected 

to change the dates and times, addresses 

and written public comment and should 

read as follows: 

DATES: The meeting will be held on 

August 30, 2021, from 10:00 a.m. to 4:00 

p.m., EDT (times subject to change). The 

docket will close on August 30, 2021. 

Written comments must be received on 

or before August 30, 2021. 

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. The meeting is 

open to the public. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0089 by any of the following methods: 

• 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– 

Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 52685 

4027, Attn: August 30, 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. 

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. 

The Secretary of Health and Human 

Services has determined that COVID–19 

is a Public Health Emergency. 

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. 

Public Participation 

Written Public Comment: The docket 

will close on August 30, 2021. Written 

comments must be received on or before 

August 30, 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. 2021–20478 Filed 9–21–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0921] 

B. Braun Medical, Inc.; Withdrawal of 

Approval of Abbreviated New Drug 

Application of Hydroxyethyl Starch 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of abbreviated 

new drug application (ANDA) 

BA110013/0032 for 6 Percent 

Hydroxyethyl Starch 130/0.4 in 0.9 

Percent Sodium Chloride Injection in 

EXCEL® Plastic Container, held by B. 

Braun Medical, Inc. B. Braun Medical, 

Inc., requested in writing that the 

Agency’s approval of the application be 

withdrawn because the drug is no 

longer being marketed and has waived 

its opportunity for a hearing. 

DATES: Approval is withdrawn as of 

October 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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: B. Braun 

Medical Inc., 901 Marcon Blvd., 

Allentown, PA 18109, has requested 

that FDA withdraw approval of ANDA 

BA110013/0032, pursuant to 

§ 314.150(c) (21 CFR 314.150(c)), 

because the drug is no longer being 

marketed. By its request, B. Braun 

Medical Inc. has also waived its 

opportunity for a hearing. Withdrawal 

of approval of an application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Proprietary name 

ANDA BA 110013/0032 ..... 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection in EXCEL® Plastic Container. 

Therefore, approval of the application 

listed in the table, and all amendments 

and supplements thereto, is hereby 

withdrawn as of October 22, 2021. 

Introduction or delivery for introduction 

into interstate commerce for products 

without an approved new drug 

application or ANDA violates section 

301(a) and (d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 331(a) and 

(d)). The drug product that is listed in 

the table above that is in inventory on 

October 22, 2021 may continue to be 

dispensed until the inventory has been 

depleted or the drug product has 

reached its expiration date or otherwise 

becomes violative, whichever occurs 

first. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20511 Filed 9–21–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3326] 

Reauthorization of the Biosimilar User 

Fee Act; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

hosting a virtual public meeting to 

discuss proposed recommendations for 

the reauthorization of the Biosimilar 

User Fee Act (BsUFA) for fiscal years 

(FYs) 2023 through 2027. The BsUFA 

authorizes FDA to collect user fees to 

support the process for the review of 

biosimilar biological product 

applications. The current legislative 

authority for BsUFA expires in 

September 2022. At that time, new 

legislation will be required for FDA to 

continue collecting user fees in future 

fiscal years. Following discussions with 

the regulated industry and consultations 

with public stakeholders, the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) directs FDA to publish the 

recommendations for the reauthorized 

program in the Federal Register, hold a 

meeting at which the public may 

present its views on such 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations. FDA will then 

consider such public views and 

comments and revise such 

recommendations, as necessary. 

DATES: The public meeting will be held 

on November 2, 2021, from 9 a.m. to 12 

p.m. Eastern Time, and will be held by 

webcast only. Submit either electronic 

or written comments on this public