Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Correction, 52669-52670 [2011-21487]
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Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices
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52669
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–21535 Filed 8–22–11; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2011–N–0332]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice of availability that appeared in
the Federal Register of August 4, 2011
(76 FR 47211). The Agency is required
to report annually in the Federal
Register on the status of postmarketing
requirements and commitments
required of, or agreed upon by, holders
of approved drug and biological
products. The August 4, 2011, notice is
the Agency’s report on the status of the
studies and clinical trials that
applicants have agreed to, or are
required to, conduct. The document was
published with an error. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy and
Planning, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9148.
In FR Doc.
2011–19806, appearing on page 47211
in the Federal Register of August 4,
2011, the following correction is made:
On page 47214, table 1 is corrected to
read as follows:
TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS
[Numbers as of September 30, 2010]
NDA/ANDA (% of Total PMR or
% of total PMC)
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Number of open PMRs .............................................................................
On-schedule open PMRs (see table 2 of this document) .................
Off-schedule open PMRs (see table 3 of this document) .................
Number of open PMCs 2 ...........................................................................
On-schedule open PMCs (see table 4 of this document) .................
Off-schedule open PMCs (see table 5 of this document) .................
526
477 (91%)
49 (9%)
473
399 (84%)
74 (16%)
BLA (% of Total PMR or % of
total PMC) 1
149.
131 (88%).
18 (12%).
307.
236 (77%).
71 (23%).
1 On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently,
CDER now reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this table.
2 The number of PMCs reported as open as of September 30, 2009, in the ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments’’ notice published in the Federal Register on November 9, 2010 (75 FR 68802), inadvertently also included open PMRs. That error has been corrected for the current reporting period.
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Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices
Dated: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–21487 Filed 8–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
2011 Technology Transfer Summit
North America Conference
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice of Conference.
AGENCY:
The NIH Office of Technology
Transfer extends invitations to attend
the 2011 Technology Transfer Summit
North America Conference.
DATES: October 3–4, 2011.
ADDRESSES: NIH campus, 9000
Rockville Pike, Bethesda MD, NIH
Clinical Center (Building 10), Masur
Auditorium.
SUPPLEMENTARY INFORMATION: The NIH
campus in Bethesda, MD will be the site
for the 2011 Tech Transfer Summit
North America (TTSNA), the leading
early-stage biotech partnering, licensing,
venture and innovation platform, cohosted and co-sponsored by the NIH
Office of Technology Transfer, TTS Ltd.
and regional host partners such as BIO
Maryland.
TTSNA is one of a series of summits
held within the Global Tech Transfer
Initiative and is designed specifically to
put innovators, early-stage SMEs and
technology managers from leading
universities and research institutes
together with biotech & pharma
licensing & business development
executives, VCs, serial entrepreneurs,
and leading IP specialists for interactive
sessions relating to partnering, licensing
& business development.
Conference speakers for the 2011
include:
—Kathy Hudson, Deputy Director,
National Institutes of Health (NIH)
—James C. Greenwood, President &
CEO, BIO
—Shiv Krishnan, Director, Scouting &
Partnering, Sanofi, USA
—Sanjeev Munshi, Director, Licensing
and External Research, Merck & Co
—David Kaslow, Head of Vaccines
Project & Pipeline Leadership, Merck
& Co
—Ed Mascioli, Head of Orphan &
Genetic Diseases Research Unit, Pfizer
—Arthur Tzianabos, Vice President of
Research, HGT Division, Shire
—Steve Groft, Director, Office of Rare
Diseases Research, NIH
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SUMMARY:
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—Phil Ross, Managing Director,
Healthcare, JPMorgan
—Maarten deJong, Managing Director,
Barclays Capital
—Andrew Robertson, Chief Policy
Officer, BIO Ventures for Global
Health
—Orin Herskowitz, Executive Director &
Vice President, Intellectual Property
Technology Transfer, Columbia
Technology Ventures
—Erik Lium, Assistant Vice Chancellor
of Research, UCSF
—Brian Kelly, Director, Technology,
Enterprise & Commercialisation, Weill
Cornell Medical College
—Daniel Perez, Partner, Bay City Capital
—Hubert Birner, Partner, TVM Capital
—Glen Steinbach, COO, Johns Hopkins
Technology Transfer
—Markus Goebel, Managing Director,
Novartis Venture Fund
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Summit will strive to induce
interactive debate, deliberation and
discussion, networking and business
over the 2-day period with the leaders
in the sector. The Summit conference
will be further enhanced by the TTS
Initiative Business Social Network, an
online business-networking platform
powered by JuJaMa. The Network is a
communication tool for business that
will allow the posting of profiles and
technology offers; the searching of other
participants by category, by technology
or licensing offer; and the setting up of
meetings prior to, during and after the
Summit. Total participation numbers for
this conference will be strictly limited
to ensure the ideal environment for real
discussion and business.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Targeting Resistance in
Select Gram-Negative Pathogens.
Date: September 22–23, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Silver Spring, 8727 Colesville
Road, Chesapeake Room, Silver Spring, MD
20910.
Contact Person: Nancy Lewis Ernst, PhD,
Scientific Review Official, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–451–7383,
nancy.ernst@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
FOR FURTHER INFORMATION CONTACT:
More details about the conference
including registration information and
the conference agenda can be found by
contacting Tech Transfer Summit North
America (https://
www.techtransfersummit.com/
northamerica2011). Attendees may also
enter the Partner Code ‘‘NIH11’’ to
register with a 10% reduction. For
information about sign language
interpretation or accommodation for
disabilities, please contact Sharon
Fields at telephone 301–594–7700 or
fieldssh@od.nih.gov.
Dated: August 16, 2011.
Steven M. Ferguson,
Deputy Director, Licensing &
Entrepreneurship, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2011–21514 Filed 8–22–11; 8:45 am]
BILLING CODE 4140–01–P
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National Institutes of Health
National Institute of Allergy and
Infectious Diseases 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.
Dated: August 17, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–21512 Filed 8–22–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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
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[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52669-52670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0332]
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
of availability that appeared in the Federal Register of August 4, 2011
(76 FR 47211). The Agency is required to report annually in the Federal
Register on the status of postmarketing requirements and commitments
required of, or agreed upon by, holders of approved drug and biological
products. The August 4, 2011, notice is the Agency's report on the
status of the studies and clinical trials that applicants have agreed
to, or are required to, conduct. The document was published with an
error. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 3208, Silver Spring, MD 20993-0002, 301-796-9148.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-19806, appearing on page
47211 in the Federal Register of August 4, 2011, the following
correction is made:
On page 47214, table 1 is corrected to read as follows:
Table 1--Summary of Postmarketing Requirements and Commitments
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of Total
Total PMR or % of PMR or % of total
total PMC) PMC) \1\
------------------------------------------------------------------------
Number of open PMRs............ 526 149.
On-schedule open PMRs (see 477 (91%) 131 (88%).
table 2 of this document).
Off-schedule open PMRs (see 49 (9%) 18 (12%).
table 3 of this document).
Number of open PMCs \2\........ 473 307.
On-schedule open PMCs (see 399 (84%) 236 (77%).
table 4 of this document).
Off-schedule open PMCs (see 74 (16%) 71 (23%).
table 5 of this document).
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
therapeutic products formerly regulated by CBER into CDER.
Consequently, CDER now reviews many BLAs. Fiscal year statistics for
postmarketing requirements and commitments for BLAs reviewed by CDER
are included in BLA totals in this table.
\2\ The number of PMCs reported as open as of September 30, 2009, in the
``Report on the Performance of Drug and Biologics Firms in Conducting
Postmarketing Requirements and Commitments'' notice published in the
Federal Register on November 9, 2010 (75 FR 68802), inadvertently also
included open PMRs. That error has been corrected for the current
reporting period.
[[Page 52670]]
Dated: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21487 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P
