[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64938-64939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] 
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: [email protected].

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:
     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)

     Active pharmaceutical ingredients manufactured by:

[cir] Chemical synthesis
[cir] Fermentation
[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 packaging
[cir] Isolators
[cir] Spray-drying
[cir] Process analytical technology, measurement systems, and real-time 
release testing

     Advanced manufacturing technologies:

[cir] Continuous manufacturing
[cir] 3-dimensional printing
[cir] Nanotechnology

     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 [email protected] (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:
     A contact person,
     Site visit location(s),
     Facility Establishment Identifier and D-U-N-S numbers, as 
applicable,
     Maximum number of FDA staff that can be accommodated 
during a site visit (maximum of 15, on average),
     A proposed agenda outlining the learning objectives and 
associated activities for the site visit,
     Maximum number of site visits your site would be willing 
to host by the close of the Government fiscal year, September 30, 2025, 
and
     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