Center for Scientific Review: Notice of Closed Meetings, 32967-32968 [2015-14186]
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
As described in this document, the
application holders agreed to
voluntarily remove their respective 32
mg, single IV dose ondansetron
products from the market, and requested
that FDA withdraw approval of their
respective applications (listed in the
preceding table) under § 314.150(d) (21
CFR 314.150(d)). On December 4, 2012,
FDA issued an updated Drug Safety
Communication alerting health care
professionals that these products would
be removed from the market because of
their potential for serious cardiac risks.
Baxter’s Ondansetron (ondansetron
HCl) Injection, USP in PL 2408 Plastic
Container, 32 mg/50 mL, single IV dose,
was approved in NDA 021915 on
December 27, 2006. In a letter dated
November 27, 2012, Baxter requested
withdrawal of NDA 021915 under 21
CFR 314.150(d), and waived its
opportunity for a hearing provided
under § 314.150(a). In a letter dated
September 5, 2012, Baxter notified FDA
that the product was being
discontinued. In a contemporaneous
notice, FDA is announcing its
determination that the product was
withdrawn from sale for reasons of
safety or effectiveness and that FDA will
not accept or approve ANDAs that refer
to this drug product.
Hospira’s ondansetron HCl Injection
32 mg/50 mL, single IV dose was
approved in ANDA 077348 on February
1, 2007. In a letter dated January 31,
2013, Hospira requested withdrawal of
ANDA 077348 under 21 CFR
314.150(d), and waived its opportunity
for a hearing provided under
§ 314.150(a).
Teva’s ondansetron HCl Injection 32
mg/50 mL, single IV dose was approved
in ANDA 077480 on November 22,
2006. In a letter dated November 20,
2012, Teva requested withdrawal of
ANDA 077480 under 21 CFR
314.150(d), and waived its opportunity
for a hearing provided under
§ 314.150(a).
Bedford’s ondansetron HCl Injection
32 mg/50 mL, single IV dose was
approved in ANDA 078291 on April 13,
2009. In a letter dated April 4, 2014,
Bedford requested withdrawal of ANDA
078291, under 21 CFR 314.150(d), and
waived its opportunity for a hearing
provided under § 314.150(a).
Claris’s ondansetron HCl Injection 32
mg/50 mL, single IV dose, was approved
in ANDA 078308 on March 17, 2008. In
a letter dated November 16, 2012,
through its U.S. agent, CUSTOpharm,
Inc., Claris requested withdrawal of
ANDA 078308 under 21 CFR
314.150(d), and waived its opportunity
for a hearing provided under
§ 314.150(a).
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Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and 21
CFR 314.150(d), and under authority
delegated by the Commissioner to the
Director, Center for Drug Evaluation and
Research, approval of the applications
listed in the table of this document, and
all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of these products 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)). The Agency
will remove these products from the list
of drug products with effective
approvals published in FDA’s
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
generally referred to as the ‘‘Orange
Book.’’
Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14144 Filed 6–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Dry Eye and Lacrimal Gland.
Date: June 15, 2015.
Time: 4:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alessandra C Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205
PO 00000
Frm 00039
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32967
MSC7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 5, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–14185 Filed 6–9–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review: Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Infectious, Reproductive, Asthma,
and Pulmonary Conditions.
Date: July 2, 2015.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Ellen K. Schwartz, Ed.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144,
MSC 7770, Bethesda, MD 20892, 301–828–
6146, schwarel@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bioengineering Sciences Member Conflict.
Date: July 7–9, 2015.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
E:\FR\FM\10JNN1.SGM
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32968
Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
Contact Person: Joseph Thomas Peterson,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9694, petersonjt@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Radiation Therapy and Biology
SBIR/STTR.
Date: July 8–9, 2015.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Bo Hong, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD
20892, 301–996–6208, hongb@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 5, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–14186 Filed 6–9–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed collection; 60-day comment
request Information Program on
Clinical Trials: Maintaining a Registry
and Results Databank (NLM)
In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Library of Medicine (NLM),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval. This summary
describes the existing information
collection at ClinicalTrials.gov, for
which an extension is requested; it does
not include any changes to the
SUMMARY:
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies,
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and submit results
information voluntarily, FDAAA
requires the registration of certain
applicable clinical trials of drugs and
devices and the submission of results
information for completed applicable
clinical trials of drugs and devices that
are approved, licensed, or cleared by the
Food and Drug Administration.
Beginning in 2009, results information
was required to include information
about serious and frequent adverse
events.
This extension request does not
include any changes to the information
submission requirements for
ClinicalTrials.gov that were proposed in
the Notice of Proposed Rulemaking on
Clinical Trial Registration and Results
Submission that was issued on
November 21, 2014 and for which the
public comment period closed on March
23, 2015 (79 FR 225, Nov. 21, 2014). The
NIH is continuing to review submitted
public comments as it prepares the final
rule. The NIH will make any
corresponding changes to the
ClinicalTrials.gov information
collection via separate procedure.
OMB approval is requested for 3
years. The total estimated annualized
cost to respondents is $49,399,851. The
total estimated annualized burden hours
are 682,535.
information collection that were
proposed in the Notice of Proposed
Rulemaking on Clinical Trial
Registration and Results Submission
that was issued on November 21, 2014
(79 FR 225, Nov. 21, 2014).
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: David Sharlip, Office of
Administrative and Management
Analysis Services, National Library of
Medicine, Building 38A, Room B2N12,
8600 Rockville Pike, Bethesda, MD
20894, or call non-toll-free number (301)
402–9680, or Email your request,
including your address to: sharlipd@
mail.nih.gov Formal requests for
additional plans and instruments must
be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank (NLM),
0925–0586, Expiration Date: 08/31/
2015, EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
PRS Account ...................................................................................................
Initial Registration ............................................................................................
Updates ............................................................................................................
Initial Results ...................................................................................................
Updates ............................................................................................................
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Number of
response per
respondent
5,700
23,000
23,000
3,700
3,700
E:\FR\FM\10JNN1.SGM
1
1
8
1
2
10JNN1
Average
time per
response
15/60
7
2
25
8
Annual
hour
burden
1,425
161,000
368,000
92,500
59,200
]]>Agencies
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32967-32968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts: Infectious, Reproductive, Asthma, and
Pulmonary Conditions.
Date: July 2, 2015.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Ellen K. Schwartz, Ed.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD
20892, 301-828-6146, schwarel@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Bioengineering Sciences Member Conflict.
Date: July 7-9, 2015.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
[[Page 32968]]
Contact Person: Joseph Thomas Peterson, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD
20892, 301-408-9694, petersonjt@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Radiation Therapy and Biology SBIR/STTR.
Date: July 8-9, 2015.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Bo Hong, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-
6208, hongb@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: June 5, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-14186 Filed 6-9-15; 8:45 am]
BILLING CODE 4140-01-P
