Training Program for Regulatory Project Managers; Information Available to Industry, 68823 [E6-20041]
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Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Notices
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20032 Filed 11–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0468]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
ycherry on PROD1PC61 with NOTICES
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 notice 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 January 29, 2007.
ADDRESSES: Submit written proposed
agendas regarding the Site Tours
Program to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, or to Beth
Duvall-Miller (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: 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, 301–
796–0700.
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
VerDate Aug<31>2005
15:42 Nov 27, 2006
Jkt 211001
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 the Division of Dockets Management
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
68823
or to Beth Duvall-Miller (see
ADDRESSES).
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20041 Filed 11–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: November 29, 2006,
9 a.m.–5 p.m.; November 30, 2006,
8:30 a.m.–3 p.m.
Place: Washington Marriott Hotel, 1221
22nd Street, NW., Washington, DC 20037,
(202)–872–1500.
Status: The meeting is open to the public
with attendance limited to space availability.
Purpose: The Committee provides advice
and recommendations to the Secretary of
Health and Human Services on the following
issues: Department of Health and Human
Services’ programs that focus on reducing
infant mortality and improving the health
status of pregnant women and infants, factors
affecting the continuum of care with respect
to maternal and child health care, and
outcomes following childbirth. It also
includes strategies to coordinate the variety
of Federal, State, local and private programs
and efforts that are designed to deal with the
health and social problems impacting infant
mortality, and the implementation of the
Healthy Start program and Healthy People
2010 infant mortality objectives.
Agenda: The committee plans to discuss
the following topics: The Healthy Start
Program and its National Evaluation,
Breastfeeding Rates, Maternal and Child
Health Bureau’s Depression Activities, and
Centers for Medicare & Medicaid Services
Program update. The meeting allots
substantial time for subcommittee and full
committee discussions to formulate the
ACIM issues agenda. The items on the
agenda items are subject to change as the
Committee continues to discuss priorities.
The Committee provides a 5-minute time
limit for each public comment. Submit
comments no later than November 17, 2006.
For Further Information Contact: Anyone
requiring information regarding the
Committee can contact Peter C. van Dyck,
M.D., M.P.H., Executive Secretary, ACIM,
Health Resources and Services
Administration (HRSA), Room 18–05,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301) 443–
2170.
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Page 68823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20041]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0468]
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 notice 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 January 29, 2007.
ADDRESSES: Submit written proposed agendas regarding the Site Tours
Program to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or to
Beth Duvall-Miller (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: 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, 301-
796-0700.
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 the Division of Dockets Management or to Beth Duvall-Miller
(see ADDRESSES).
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20041 Filed 11-27-06; 8:45 am]
BILLING CODE 4160-01-S
