[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12624-12625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06327]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 June 3, 2019.

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].

[[Page 12625]]


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 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, over a 2- to 3-day period, small groups (five or 
less) of CDER 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 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 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06327 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P


