[Federal Register: September 1, 2004 (Volume 69, Number 169)]
[Page 53452-53453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0455]

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). This training program was initiated 
in 1999, and it is intended to give CDER regulatory project managers an 
opportunity to tour pharmaceutical facilities and to exchange 
regulatory experiences with their industry counterparts. The Site Tours 
Program is intended to enhance review efficiency and quality by 
providing CDER staff with a better understanding of the pharmaceutical 
industry and its operations. Further, this program is intended to 
improve communication and cooperation between CDER staff and industry. 
The purpose of this notice is to invite pharmaceutical companies 
interested in participating in these programs to contact CDER.

DATES:  Pharmaceutical companies may submit proposed agendas to the 
agency by November 1, 2004.

FOR FURTHER INFORMATION CONTACT:  Beth Duvall-Miller, Office of New 
Drugs (HFD-020), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5515 Security Lane, rm. 7219, Rockville, MD 20852, 301-
594-3937, FAX: 301-480-8329.


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, the 
center has initiated various training and development programs to 
promote high performance

[[Page 53453]]

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 this 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. Regulatory Project Management Site Tours and Regulatory Interaction 

    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, project 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 within 60 days of this notice 
by submitting a proposed agenda to Beth Duvall-Miller (see FOR FURTHER 

    Dated: August 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19879 Filed 8-31-04; 8:45 am]