Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch, 70141 [2021-26648]
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
equivalence) for a new tobacco product
(section 905(j)(1)A)(i) of the FD&C Act
(21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the
manufacturer submit information
adequate to demonstrate that the
tobacco product was commercially
marketed in the United States as of
February 15, 2007. Examples of such
information may include, but are not
limited to, the following: Dated copies
No. of
respondents
Activity
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
1 There
1,000
FDA estimates the burden of this
collection of information as follows:
Total annual
responses
1
Average
burden per
response
(in hours)
1,000
Total hours
5
5,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents is based on the fact that
requesting an Agency determination of
the Pre-Existing status of a tobacco
product under the guidance is not
required and also on the number of PreExisting tobacco product submissions
received from 2011 to October 2021. For
deemed products that met the definition
of a new tobacco product and were on
the market as of August 8, 2016 (when
the deeming rule took effect), FDA
issued a compliance policy; this, in
effect, provided more time for
manufacturers of these products to
submit their applications for marketing
authorization. The deadline for the
submission of applications for these
products has now passed. As the result
of a court order (and a subsequent
extension due to the unique
circumstances of the COVID–19
pandemic), applications for deemed
new tobacco products on the market at
that time were due to FDA by
September 9, 2020.2 The court order
also provided a 1-year period during
which products with timely filed
applications might remain on the
market pending FDA review. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
take a manufacturer to review, gather,
and submit dated information if making
a request for Agency determination.
FDA further estimates it would take a
manufacturer approximately 5 hours to
put together this collection of evidence
and to submit the package to FDA for
review. FDA estimates that it would
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No. of
responses per
respondent
of advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
2 On August 19, 2020, the U.S. District Court for
the District of Columbia issued a ruling, in part, to
prohibit FDA enforcement of the Tobacco Control
Act’s premarket authorization requirement for
premium cigars until after the agency considers
developing a streamlined substantial equivalence
process specifically for premium cigars.
Accordingly, FDA will not enforce the premarket
review requirement against manufacturers of
premium cigars that do not submit premarket
applications for these products by the September 9,
2020 deadline.
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17:41 Dec 08, 2021
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take approximately 5,000 hours
annually to respond to this collection of
information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26652 Filed 12–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Fresenius Kabi Deutschland GmbH;
Withdrawal of Approval of New Drug
Application of Hydroxyethyl Starch
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of a new drug
application (NDA) BN 070012/0022 for
VOLUVEN (6 Percent Hydroxyethyl
Starch 130/0.4 in 0.9 Percent Sodium
Chloride Injection), held by Fresenius
Kabi Deutschland GmbH. Fresenius
Kabi Deutschland GmbH 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.
SUMMARY:
Approval is withdrawn as of
January 10, 2022.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
DATES:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Fresenius
Kabi Deutschland GmbH, Bad Homburg,
Germany (Authorized U.S. Agent:
Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL 60047),
has requested that FDA withdraw
approval of NDA BN 070012 sequence
0022, pursuant to § 314.150(c) (21 CFR
314.150(c)), because the drug is no
longer being marketed. By its request,
Fresenius Kabi Deutschland GmbH, 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:
Application No.
[Docket No. FDA–2021–N–1194]
AGENCY:
Silver Spring, MD 20993–0002, 240–
402–7911.
Proprietary name
NDA BN
VOLUVEN (6% Hydroxyethyl
070012/0022.
Starch 130/0.4 in 0.9%
Sodium Chloride Injection)
Therefore, approval of the application
listed in the table, and all amendments
and supplements thereto, is hereby
withdrawn as of January 10, 2022.
Introduction or delivery for introduction
into interstate commerce for products
without a new drug application 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 January 10, 2022 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: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26648 Filed 12–8–21; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Page 70141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26648]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1194]
Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of 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 a new drug application (NDA) BN 070012/0022 for
VOLUVEN (6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium
Chloride Injection), held by Fresenius Kabi Deutschland GmbH. Fresenius
Kabi Deutschland GmbH 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 January 10, 2022.
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: Fresenius Kabi Deutschland GmbH, Bad
Homburg, Germany (Authorized U.S. Agent: Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL 60047), has requested that FDA withdraw
approval of NDA BN 070012 sequence 0022, pursuant to Sec. 314.150(c)
(21 CFR 314.150(c)), because the drug is no longer being marketed. By
its request, Fresenius Kabi Deutschland GmbH, 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
------------------------------------------------------------------------
NDA BN 070012/0022..................... VOLUVEN (6% Hydroxyethyl Starch
130/0.4 in 0.9% Sodium
Chloride Injection)
------------------------------------------------------------------------
Therefore, approval of the application listed in the table, and all
amendments and supplements thereto, is hereby withdrawn as of January
10, 2022. Introduction or delivery for introduction into interstate
commerce for products without a new drug application 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 January 10, 2022 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: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26648 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P
