[Federal Register Volume 70, Number 249 (Thursday, December 29, 2005)]
[Notices]
[Pages 77168-77169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8017]


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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.

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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 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 February 27, 2006.

FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Office of New 
Drugs (HFD-020), Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg 22, rm. 6466, Silver 
Spring, MD 20903, 301-796-0700, FAX: 301-796-9858.

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, the 
Center 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. Regulatory Project Management Site Tours and Regulatory Interaction 
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

[[Page 77169]]

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 within 60 days of this notice 
by submitting a proposed agenda to Beth Duvall-Miller (see FOR FURTHER 
INFORMATION CONTACT).

    Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8017 Filed 12-28-05; 8:45 am]
BILLING CODE 4160-01-S