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:

○ Solutions, suspensions, emulsions, semisolids, and solids

○ Modified- and immediate-release formulations

○ 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:

○ Chemical synthesis

○ Fermentation

○ Biotechnology

• Design, development, manufacturing, and controls:

○ Engineering controls for aseptic processes

○ Novel delivery technologies

○ Hot melt extrusion

○ Soft-gel encapsulation

○ Lyophilization

○ Blow-Fill-Seal packaging

○ Isolators

○ Spray-drying

○ Process analytical technology, measurement systems, and real-time release testing

• Advanced manufacturing technologies:

○ Continuous manufacturing

○ 3-dimensional printing

○ Nanotechnology

• Terminal sterilization:

○ Gamma irradiation

○ PET drug manufacturing and controls

○ 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 ( printed page 64939) visit program should respond by submitting a proposal directly to Lyle Canida at CDEROPQSiteVisits@fda.hhs.gov (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.

89 FR 64938