Notice2024-17640
Office of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcement
Primary source
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Published
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP). 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.
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64938-64939]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3449]
Office of Pharmaceutical Quality Experiential Learning Site Visit
Program; Program Announcement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ)
Experiential Learning Site Visit Program (ELSVP). 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: Starting October 1, 2024, FDA will accept requests to
participate in the ELSVP program.
ADDRESSES: If your facility is interested in offering a site visit,
submit either an electronic proposal to <a href="/cdn-cgi/l/email-protection#d99a9d9c8b9689888ab0adbc8fb0aab0adaa99bfbdb8f7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="72313637203d2223211b0617241b011b0601321416135c1a1a015c151d04">[email protected]</span></a>
or a written proposal to Lyle Canida (see FOR FURTHER INFORMATION
CONTACT). See the ``III. Site Selection'' and ``IV. Proposals for
Participation'' sections of this document for potential priorities
onsite selection criteria and how to submit a proposal to participate
in the program.
FOR FURTHER INFORMATION CONTACT: Lyle Canida, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. M4522, Silver Spring, MD 20993-0002, 301-
796-6825, email: <a href="/cdn-cgi/l/email-protection#2b686f6e79647b7a78425f4e7d4258425f586b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="bffcfbfaedf0efeeecd6cbdae9d6ccd6cbccffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
A critical part of the commitment by CDER to assure safe and
effective high-quality drugs are available to the American public is
gaining an understanding of all aspects of a drug's development and
commercial lifecycle, including the variety of drug manufacturing
operations. To support this commitment, CDER has initiated various
training and development programs, including the FY2025 OPQ ELSVP. 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 may 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 Experiential Learning Site Visit Program (ELSVP)
In this site visit program, groups on average of no more than 15
OPQ staff--who have experience in a variety of educational backgrounds,
supporting pharmaceutical quality assessment--will observe operations
or important aspects 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.
CDER encourages companies engaging in the development and
manufacturing of both active pharmaceutical ingredients (small and
large molecules) and drug products to respond.
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, the following list
identifies a number of areas of particular interest to its staff. The
list is not intended to be exhaustive, mutually exclusive, or to limit
industry response:
<bullet> Drug products:
[cir] Solutions, suspensions, emulsions, semisolids, and solids
[cir] Modified- and immediate-release formulations
[cir] Drug-device combination products regulated by CDER (e.g.,
inhalation products, transdermal systems, implants intended for drug
delivery, and pre-filled 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 packaging
[cir] Isolators
[cir] Spray-drying
[cir] Process analytical technology, measurement systems, and real-time
release testing
<bullet> Advanced manufacturing technologies:
[cir] Continuous manufacturing
[cir] 3-dimensional printing
[cir] Nanotechnology
<bullet> Terminal sterilization:
[cir] Gamma irradiation
[cir] PET drug manufacturing and controls
[cir] Medical gas manufacturing and controls
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 CDER Offices; therefore, the number of sites selected
will be based on the availability of funds and resources for the fiscal
year. FDA 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
[[Page 64939]]
visit program should respond by submitting a proposal directly to Lyle
Canida at <a href="/cdn-cgi/l/email-protection#7c3f38392e332c2d2f1508192a150f15080f3c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="c88b8c8d9a8798999ba1bcad9ea1bba1bcbb88aeaca9e6a0a0bbe6afa7be">[email protected]</span></a> (see the 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 D-U-N-S numbers, as
applicable,
<bullet> Maximum number of FDA staff that can be accommodated
during a site visit (maximum of 15, on average),
<bullet> A proposed agenda outlining the learning objectives and
associated activities for the site visit,
<bullet> Maximum number of site visits your site would be willing
to host by the close of the Government fiscal year, September 30, 2025,
and
<bullet> Proposed time frames for each site visit (i.e., month or
quarter).
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
consider alternative pathways to meeting our training goals.
Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17640 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P
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