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Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 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
3.150b, less than 15 calendar days notice is being given for this meeting due to the exceptional circumstances of the COVID19 pandemic and rapidly evolving COVID19 vaccine development and regulatory processes.
The Secretary of Health and Human Services has determined that COVID19
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, MSH248, Atlanta, GA 30329
4027; Telephone: 4046398367; Email:
ACIP@cdc.gov.

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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0921

B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch AGENCY:

Food and Drug Administration,
HHS.
Notice.

Public Participation
ACTION:

Written Public Comment: The docket will close on August 30, 2021. Written
SUMMARY:

The Food and Drug Administration FDA or Agency is
Application No.
ANDA BA 110013/0032

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 Agencys approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Approval is withdrawn as of October 22, 2021.

DATES:

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 209930002, 240
4027911.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109, has requested that FDA withdraw approval of ANDA
BA110013/0032, pursuant to 314.150c 21 CFR 314.150c, 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 314.150c is without prejudice to refiling.

SUPPLEMENTARY INFORMATION:

Proprietary name 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 301a and d of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 331a 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2015N3326

Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments AGENCY:

Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.

ACTION:

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
SUMMARY:

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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.
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
DATES:

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