82 FR 57280 - 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 82, Issue 231 (December 4, 2017)

The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 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 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57280]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26055]



[[Page 57280]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6286]


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 2018 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 February 2, 2018. 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 the 
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 2018 
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 the challenges 
that impact a drug's developmental 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 in operational status is an 
integral part of the experience.

II. The Site Visit Program

    In this site visit program, groups on average of 15 to 20 OPQ 
staff--who have experience in a variety of backgrounds, including 
science, medical, statistics, manufacturing, engineering, and testing--
will observe operations of commercial manufacturing, pilot plants, and 
testing operations 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 active pharmaceutical ingredients (small and 
large molecules) and drug products to respond. However, please note 
that this site visit program is not intended to supplement or replace a 
regulatory inspection, e.g., a preapproval inspection, pre-license 
inspection, or a surveillance inspection. OPQ staff participating in 
this program will benefit 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 examples of these areas but is not intended to be 
exhaustive, mutually exclusive, or to limit industry response:
     Drug products:
    [cir] Solutions, suspensions, emulsions, and semisolids;
    [cir] modified- and immediate-release formulations; and
    [cir] drug-device combination products (e.g., inhalation products, 
transdermal products,implants intended for drug delivery, and pre-
filled syringes).
     Active pharmaceutical ingredients manufactured by:
    [cir] Chemical synthesis;
    [cir] fermentation; and
    [cir] biotechnology
     Design, development, manufacturing, and controls:
    [cir] Engineering controls for aseptic processes;
    [cir] novel delivery technologies;
    [cir] hot melt extrusion;
    [cir] soft-gel encapsulation;
    [cir] lyophilization;
    [cir] blow-fill-seal and isolators;
    [cir] spray-drying; and
    [cir] process analytical technology, measurement systems, and real 
time release testing.
     Emerging technologies:
    [cir] Continuous manufacturing;
    [cir] 3-dimensional printing; and
    [cir] nanotechnology.

III. Site Selection

    Selection of potential facilities will be based on the priorities 
developed for OPQ staff training, the facility's current compliance 
status with FDA, and 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 FOR FURTHER INFORMATION CONTACT). To aid 
in OPQ's site selection and planning, your proposal should include the 
following information:
     A contact person;
     site visit location(s);
     Facility Establishment Identifier and Data Universal 
Numbering System numbers, as applicable;
     maximum number of FDA staff that can be accommodated 
during a site visit (maximum of 20);
     a sample agenda outlining the proposed learning objectives 
and associated activities for the site visit;
     number of visits (no more than two) your site would be 
willing to host by the close of the government fiscal year, September 
30, 2018; and
     months the site is operational that would be ideal for a 
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 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26055 Filed 12-1-17; 8:45 am]
BILLING CODE 4164-01-P