[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Page 10538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0093]


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's (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 April 23, 2012.

FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 4160, Silver Spring, MD 20993-0002, 301-796-0578, email: 
[email protected].

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) 
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. 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 
submitting a proposed agenda to Dan Brum (see DATES and FOR FURTHER 
INFORMATION CONTACT).

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4034 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P