[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42903-42904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3030]


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 Fiscal Year 2019 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 November 23, 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: <a href="/cdn-cgi/l/email-protection#c3808786918c939290aab7a695aab0aab7b083a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="3f7c7b7a6d706f6e6c564b5a69564c564b4c7f595b5e1157574c11585049">[email protected]</span></a>.

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 a drug's development and 
commercial life cycle, including the variety of drug manufacturing 
operations. To support this commitment, CDER has initiated various 
training and development programs including the FY2019 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 enhance OPQ staff exposure to the drug development 
and manufacturing processes in industry; therefore, a tour of 
pharmaceutical company facilities, including manufacturing and 
laboratory operations, 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, medicine, statistics, manufacturing, engineering, testing, and 
project management--will observe operations of commercial 
manufacturing, pilot plants (if applicable), 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, 
manufacturing and testing may be included.
    OPQ encourages companies engaging in the development and 
manufacturing of both active pharmaceutical ingredients (small and 
large molecules) and drug products to respond. Please note that this 
site visit program is not intended to supplement or replace a 
regulatory inspection, e.g., a preapproval inspection, prelicense 
inspection, or a surveillance inspection.

[[Page 42904]]

    OPQ staff participating in this program will benefit by gaining a 
better understanding of current industry practices, processes, and 
procedures. Participating sites will have an opportunity to showcase 
their technologies and their actual manufacturing and testing 
facilities.
    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:

<bullet> Drug products
[cir] Solutions, suspensions, emulsions, and semisolids
[cir] Modified- and immediate-release formulations
[cir] Drug-device combination products (e.g., inhalation products, 
transdermal systems, implants intended for drug delivery, and prefilled 
syringes)
<bullet> Active pharmaceutical ingredients manufactured by
[cir] Chemical synthesis
[cir] Fermentation
[cir] Biotechnology
<bullet> 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
[cir] Process analytical technology, measurement systems, and real-time 
release testing
<bullet> 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 compliance 
status with FDA, and in 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 DATES and FOR FURTHER INFORMATION CONTACT 
sections of this document for more information). To aid in OPQ's site 
selection and planning, your proposal should include the information 
below:
    <bullet> A contact person,
    <bullet> Site visit location(s),
    <bullet> Facility Establishment Identifier and Data Universal 
Numbering System numbers, as applicable,
    <bullet> Maximum number of FDA staff that can be accommodated 
during a site visit (maximum of 20),
    <bullet> A proposed agenda outlining the learning objectives and 
associated activities for the site visit,
    <bullet> Maximum number of site visits (no more than 2) that your 
site would be willing to host by the close of the government fiscal 
year, September 30, 2019, and
    <bullet> Proposed dates for each site visit (i.e. month and week).
    Please note that the requested proposed agenda will be reviewed to 
determine the educational benefit to OPQ in conducting the visit, and 
selected sites may be asked to refine the agenda to maximize the 
educational benefit. After a site is selected, OPQ will communicate 
with the contact person for the site to determine the actual dates for 
the 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: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18305 Filed 8-23-18; 8:45 am]
 BILLING CODE 4164-01-P


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