Document ID: FDA-2010-N-0108-0001
Agency: fda
Document Type: Notice
Title: Information Available to Industry: Training Program for Regulatory Project Managers
Posted Date: 2010-03-09T05:00Z

[Federal Register: March 9, 2010 (Volume 75, Number 45)]
[Notices]               
[Page 10806-10807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr10-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0108]

 
Training Program for Regulatory Project Managers; Information 
Available to Industry

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 May 10, 2010 Federal Register].

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, e-mail: 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 
significantly enhance 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) 
First hand 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

[[Page 10807]]

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. Selection 
will also be based on firms having a favorable facility status as 
determined by FDA's Office of Regulatory Affairs District Offices in 
the firms' respective regions. 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 FOR 
FURTHER INFORMATION CONTACT).

    Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4924 Filed 3-8-10; 8:45 am]
BILLING CODE 4160-01-S