Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70, 50121 [2012-20280]
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Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices
the device(s) that would be addressed
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HUMAN SERVICES
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Food and Drug Administration
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Dated: August 14, 2012.
Leslie Kux,
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[FR Doc. 2012–20323 Filed 8–17–12; 8:45 am]
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50121
Dated: August 9, 2012.
Karen Midthun,
Director, Center for Biologics Evaluation and
Research.
[FR Doc. 2012–20280 Filed 8–17–12; 8:45 am]
[Docket No. FDA–2012–N–0840]
BILLING CODE 4160–01–P
Hospira, Inc.; Withdrawal of Approval
of a New Drug Application for
DEXTRAN 70
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for DEXTRAN 70 (6% Dextran 70
and 0.9% NaCl or/5% Dextrose 500 mL
Glass Bottle) held by Hospira, Inc., 275
North Field Dr., Lake Forest, IL 60045.
Hospira, Inc., has notified the Agency in
writing that this product is no longer
marketed and has requested that
approval of the application be
withdrawn.
SUMMARY:
DATES:
Effective August 20, 2012.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852, 301–827–6210.
Hospira,
Inc., has requested that FDA withdraw
approval of NDA 080–819, DEXTRAN
70 (6% Dextran 70 and 0.9% NaCl or/
5% Dextrose 500 mL Glass Bottle) under
the process in § 314.150(c)(21 CFR
314.150(c)), stating that the product is
no longer marketed. By its own request,
Hospira, Inc., has also waived its
opportunity for a hearing provided
under § 314.150(a).
Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Biologics Evaluation
and Research, by the Commissioner of
Food and Drugs, approval of NDA 080–
819, DEXTRAN 70 [6% Dextran 70 and
0.9% NaCl or/5% Dextrose 500 mL
Glass Bottle], and all amendments and
supplements thereto, is hereby
withdrawn, effective August 20, 2012.
Distribution of this product in interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).
SUPPLEMENTARY INFORMATION:
PO 00000
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Indian Health Service
Office of Direct Service and
Contracting Tribes National Indian
Health Outreach and Education
Program Funding Opportunity
Announcement Type: New Limited
Competition.
Funding Announcement Number:
HHS–2012–IHS–NIHOE–0003.
Catalog of Federal Domestic Assistance
Number: 93.933.
Key Dates
Application Deadline Date:
September 10, 2012.
Review Date: September 12, 2012.
Earliest Anticipated Start Date:
September 30, 2012.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting competitive cooperative
agreement applications for the Office of
Direct Service and Contracting Tribes on
the National Indian Health Outreach
and Education (NIHOE–III) program
funding opportunity that includes
outreach and education activities on the
following: The Patient Protection and
Affordable Care Act, Public Law 111–
148 (PPACA), as amended by the Health
Care and Education Reconciliation Act
of 2010, Public Law 111–152,
collectively known as the Affordable
Care Act (ACA) and the Indian Health
Care Improvement Act (IHCIA), as
amended. This national outreach and
educational program is authorized
under the Snyder Act, codified at 25
U.S.C. 13, and the Transfer Act, codified
at 42 U.S.C. 2001(a). This program is
described in the Catalog of Federal
Domestic Assistance under CFDA
number 93.933.
Background
The NIHOE–III programs carry out
health program objectives in the
American Indian/Alaska Native (AI/AN)
community in the interest of improving
Indian health care for all 566 Federallyrecognized Tribes including Tribal
governments operating their own health
care delivery systems through selfdetermination contracts and compacts
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Page 50121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20280]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0840]
Hospira, Inc.; Withdrawal of Approval of a New Drug Application
for DEXTRAN 70
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9%
NaCl or/5% Dextrose 500 mL Glass Bottle) held by Hospira, Inc., 275
North Field Dr., Lake Forest, IL 60045. Hospira, Inc., has notified the
Agency in writing that this product is no longer marketed and has
requested that approval of the application be withdrawn.
DATES: Effective August 20, 2012.
FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852,
301-827-6210.
SUPPLEMENTARY INFORMATION: Hospira, Inc., has requested that FDA
withdraw approval of NDA 080-819, DEXTRAN 70 (6% Dextran 70 and 0.9%
NaCl or/5% Dextrose 500 mL Glass Bottle) under the process in Sec.
314.150(c)(21 CFR 314.150(c)), stating that the product is no longer
marketed. By its own request, Hospira, Inc., has also waived its
opportunity for a hearing provided under Sec. 314.150(a).
Withdrawal of approval of an application under Sec. 314.150(c) is
without prejudice to refiling.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Biologics Evaluation and
Research, by the Commissioner of Food and Drugs, approval of NDA 080-
819, DEXTRAN 70 [6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL
Glass Bottle], and all amendments and supplements thereto, is hereby
withdrawn, effective August 20, 2012. Distribution of this product in
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: August 9, 2012.
Karen Midthun,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 2012-20280 Filed 8-17-12; 8:45 am]
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