81 FR 80666 - Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 221 (November 16, 2016)

The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.

[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80666-80667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3744]


Site Visit Training Program for Office of Pharmaceutical Quality 
Staff; Information Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food 
and Drug Administration (FDA) is announcing the 2017 CDER Office of 
Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit 
Program. The purpose of this document is to invite pharmaceutical 
companies interested in participating in this program to submit a site 
visit proposal to CDER's OPQ.

DATES: Submit either an electronic or written proposal to participate 
in this program by January 17, 2017. See section IV of this document 
for information on what to include in such proposals.

FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240-
402-3969, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    A critical part of the commitment by CDER to make safe and 
effective high-quality drugs available to the American public is 
gaining an understanding of all aspects of drug development and a 
drug's commercial life cycle, including the variety of drug 
manufacturing operations. To support this commitment, CDER has 
initiated various training and development programs, including the 2017 
OPQ Staff Experiential Learning Site Visit Program. This site visit 
program is designed to offer experiential and firsthand learning 
opportunities that will provide OPQ staff with a better understanding 
of the pharmaceutical industry and its operations, as well as of the 
challenges that impact a drug's development program and commercial life 
cycle. The goal of these visits is to provide OPQ staff exposure to the 
drug development and manufacturing processes in industry; therefore, a 
tour of pharmaceutical company facilities is an integral part of the 
program.

II. The Site Visit Program

    In this site visit program, groups of OPQ staff--who have 
experience in a variety of backgrounds, including science, statistics, 
manufacturing, engineering and testing--will observe operations of 
commercial manufacturing, pilot plants, and testing over a 1- to 2-day 
period. To facilitate the learning process for OPQ staff, overview 
presentations by industry related to drug development and manufacturing 
may be provided, which may allow the participating sites to benefit by 
having an opportunity to showcase their technologies and manufacturing 
processes.
    OPQ encourages companies engaging in the development and 
manufacturing of both drug substances and drug products to respond. 
However, please note that this site visit program is not intended to 
supplement or to replace a regulatory inspection, e.g., a preapproval 
inspection, pre-license inspection or a surveillance inspection. OPQ 
staff participating in this program will grow professionally by gaining 
a better understanding of current industry practices, processes, and 
procedures.
    Although observation of all aspects of drug development and 
production would be beneficial to OPQ staff, OPQ has identified a 
number of areas of particular interest to its staff. The following list 
identifies some of these areas but is not intended to be exhaustive or 
to limit industry response:

 Drug products and active pharmaceutical ingredients
[cir] Solutions, suspensions, emulsions, and semisolids
[cir] Sustained, modified, and immediate release formulations
[cir] Drug-device combination products, particularly inhalation, 
transdermal, iontophoretic, and implant formulations
[cir] Biotechnology products
 Design, development, manufacturing, and controls
[cir] Engineering controls for aseptic formulations
[cir] Unique delivery technologies

[[Page 80667]]

[cir] Hot melt extrusion processes
[cir] Soft-gel encapsulation processes
[cir] Lyophilization processes
[cir] Blow-Fill-Seal and isolators
[cir] Spray-drying processes
[cir] Process analytical technology and Real Time Release Testing
 Emerging technologies
[cir] Continuous manufacturing
[cir] 3-dimensional printing
[cir] Nanotechnology

III. Site Selection

    Selection of potential facilities will be based on the priorities 
developed for OPQ staff training, the facility's current regulatory 
status with FDA, and on consultation with the appropriate FDA district 
office. All travel expenses associated with this program will be the 
responsibility of OPQ; therefore, selection will be based on the 
availability of funds and resources for the fiscal year. OPQ will not 
provide financial compensation to the pharmaceutical site as part of 
this program.

IV. Proposals for Participation

    Companies interested in offering a site visit or learning more 
about this site visit program should respond by submitting a proposal 
directly to Janet Wilson (see the DATES and FOR FURTHER INFORMATION 
CONTACT sections of this document for more information). To aid in 
OPQ's site selection, your proposal should include the following 
information:

 A contact person
 Site visit location(s)
 Facility Establishment Identifier and DUNS numbers, as 
applicable
 Maximum number of OPQ staff that can be accommodated during a 
site visit, and
 A sample agenda outlining the proposed learning objectives and 
associated activities for the site visit

Proposals submitted without this minimum information will not be 
considered. Based on response rate and type of responses, OPQ may or 
may not consider alternative pathways to meeting our training goals.

    Dated: November 9, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-27454 Filed 11-15-16; 8:45 am]
 BILLING CODE 4164-01-P