[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Pages 16451-16452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0179]


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 or the Agency) 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 send proposed agendas to the Agency 
by May 16, 2023.

FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578, 
[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 goal, CDER has 
initiated various training and development programs to promote

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high performance in its regulatory project management staff. CDER seeks 
to 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, which generally lasts a few days, small groups of 
CDER regulatory project managers, often 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, 
nonclinical and clinical evaluation, postmarketing activities, 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 Program 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 that want to learn more about this 
training opportunity or that are interested in offering a site tour 
should respond by sending a proposed agenda by email directly to Dan 
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).

    Dated: March 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05509 Filed 3-16-23; 8:45 am]
BILLING CODE 4164-01-P


