Training Program for Regulatory Project Managers; Information Available to Industry, 58668 [E7-20430]
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mmaher on PROD1PC70 with NOTICES
58668
Federal Register / Vol. 72, No. 199 / Tuesday, October 16, 2007 / Notices
Confidence assets, the Consent
Agreement provides for the Commission
to appoint a trustee to divest the assets.
Second, Disc-O-Tech is required to
provide transitional services to the
Commission-approved buyer. These
transitional services, which are similar
in form to what Disc-O-Tech would
have provided to Kyphon, may be
necessary for a smooth transition of the
Confidence assets to the acquirer and to
ensure continued and uninterrupted
service to customers during the
transition. The Consent Agreement also
requires that Kyphon covenant not to
sue the acquirer of the Confidence assets
for infringing any intellectual property
Kyphon acquired from Disc-O-Tech that
is not being divested. This covenant
covers not only the Confidence assets,
but also extends to any developments an
acquirer might make to the Confidence
assets. This provision is designed as a
safety net to ensure that Kyphon does
not interfere with the acquirer’s freedom
to compete in the U.S. MIVCF treatment
product market with a patent
infringement lawsuit based on former
Disc-O-Tech intellectual property.
Finally, to ensure that the Commission
will have an opportunity to review any
attempt by Kyphon to acquire or license
any of the Confidence assets at any time
within the next two years, the proposed
Consent Agreement contains a prior
notice provision committing Kyphon to
an H-S-R framework, even if such a
transaction otherwise would be nonreportable.
The Order to Hold Separate and
Maintain Assets that is included in the
Consent Agreement requires that DiscO-Tech maintain the viability of the
Confidence business as a competitive
operation until the business is
transferred to a Commission-approved
buyer. Specifically, Disc-O-Tech must
maintain the confidentiality of sensitive
business information, and take all
actions required to prevent the
destruction or wasting of the Confidence
assets. Kyphon may not interfere with
the Confidence business during the
pendency of the divestiture by having
any involvement in the Confidence
business, making offers of employment
to Disc-O-Tech employees involved in
the Confidence business before the
Confidence assets are divested, or
interfering with Disc-O-Tech’s suppliers
of materials for the Confidence product.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Decision
and Order or to modify its terms in any
way.
VerDate Aug<31>2005
04:12 Oct 16, 2007
Jkt 214001
By direction of the Commission, with
Commissioners Harbour and Kovacic
recused.
Donald S. Clark,
Secretary.
[FR Doc. E7–20325 Filed 10–15–07: 8:45 am]
[Billing Code: 6750–01–S]
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the agency
by December 17, 2007.
ADDRESSES: Submit written proposed
agendas regarding the Site Tours
Program to Beth Duvall-Miller, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993–0002. You can
also reach Beth Duvall-Miller by
telephone at 301–796–0700 or by e-mail
at elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
III. Site Selection
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to enhance
significantly review efficiency and
review quality by providing the staff
with a better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
PO 00000
Frm 00038
Fmt 4703
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
Sfmt 4703
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Firms
interested in offering a site tour or
learning more about this training
opportunity should respond by (see
DATES) by submitting a proposed agenda
to Beth Duvall-Miller (see ADDRESSES).
Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20430 Filed 10–15–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 72, Number 199 (Tuesday, October 16, 2007)]
[Notices]
[Page 58668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20430]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may submit proposed agendas to the
agency by December 17, 2007.
ADDRESSES: Submit written proposed agendas regarding the Site Tours
Program to Beth Duvall-Miller, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm.
6466, Silver Spring, MD 20993-0002. You can also reach Beth Duvall-
Miller by telephone at 301-796-0700 or by e-mail at
elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
enhance significantly review efficiency and review quality by providing
the staff with a better understanding of the pharmaceutical industry
and its operations. To this end, CDER is continuing its training
program to give regulatory project managers the opportunity to tour
pharmaceutical facilities. The goals are to provide the following: (1)
Firsthand exposure to industry's drug development processes and (2) a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the site tours will be the
responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Firms
interested in offering a site tour or learning more about this training
opportunity should respond by (see DATES) by submitting a proposed
agenda to Beth Duvall-Miller (see ADDRESSES).
Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20430 Filed 10-15-07; 8:45 am]
BILLING CODE 4160-01-S
