B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch, 52685 [2021-20511]

Download as PDF 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– 3.150(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. 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[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. 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by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency’s approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing. Approval is withdrawn as of October 22, 2021.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 20993–0002, 240 402–7911. 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. 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 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 VerDate Sep<11>2014 52685 16:44 Sep 21, 2021 Jkt 253001 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. 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: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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: E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Page 52685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20511]


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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.

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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[supreg] 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 Sec.  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 Sec.  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[supreg]
                                             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