Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications; Correction, 43139 [2019-17933]
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43139
Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
Hours per
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APS Leaders Interview ....................................................................................
84
16
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126
16
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Dated: August 14, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–17879 Filed 8–19–19; 8:45 am]
Food and Drug Administration
Food and Drug Administration,
HHS.
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 8, 2011. The document
announced the withdrawal of approval
of 70 new drug applications (NDAs) and
97 abbreviated new drug applications
from multiple applicants, effective July
8, 2011. The document contained the
incorrect applicant information for NDA
018380. The correct applicant for NDA
018380 is Hospira, Inc. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 8,
2011 (76 FR 33310), appearing on page
33310 in FR Doc. 2011–14164, the
following correction is made:
On page 33311, in table 1, in the
‘‘Applicant’’ column for NDA 018380,
correct the entry ‘‘Do.’’ to read ‘‘Hospira,
Inc., 275 North Field Dr., Bldg. H2, Lake
Forest, IL 60045–5046.’’
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17933 Filed 8–19–19; 8:45 am]
BILLING CODE 4164–01–P
20:49 Aug 19, 2019
Electronic Submissions
Jkt 247001
Food and Drug Administration,
HHS.
Bristol-Myers Squibb Co. et al.;
Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated
New Drug Applications; Correction
VerDate Sep<11>2014
Food and Drug Administration
AGENCY:
[Docket No. FDA–2011–N–0411]
ACTION:
acceptance receipt is on or before that
date.
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide: Version 3.1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–3500]
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ACTION:
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SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing that it intends to conduct a
Fit for Use (FFU) pilot program to test
the processing and analysis of
nonclinical study data provided
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Interchange Standards Consortium
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Nonclinical Data (SEND)
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(SEND 3.1). The Agency’s Center for
Drug Evaluation and Research (CDER)
will test the processing and analysis of
nonclinical study data provided
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is inviting individual firms that wish to
participate in this pilot program to
submit participation requests via email
or in writing.
DATES: To be considered for
participation in the pilot program,
submit electronic or written requests by
September 19, 2019. See the ADDRESSES
section for participation request
instructions.
ADDRESSES: Submit electronic requests
to participate in the pilot and comments
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www.regulations.gov. Submit written
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E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Page 43139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17933]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0411]
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of June 8, 2011. The document
announced the withdrawal of approval of 70 new drug applications (NDAs)
and 97 abbreviated new drug applications from multiple applicants,
effective July 8, 2011. The document contained the incorrect applicant
information for NDA 018380. The correct applicant for NDA 018380 is
Hospira, Inc. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, June
8, 2011 (76 FR 33310), appearing on page 33310 in FR Doc. 2011-14164,
the following correction is made:
On page 33311, in table 1, in the ``Applicant'' column for NDA
018380, correct the entry ``Do.'' to read ``Hospira, Inc., 275 North
Field Dr., Bldg. H2, Lake Forest, IL 60045-5046.''
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17933 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P
