[Federal Register Volume 89, Number 135 (Monday, July 15, 2024)]
[Notices]
[Pages 57417-57418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2908]


Cellular and Gene Therapies Interactive Site Tours Program for 
Regulatory Project Managers and Reviewers; Information Available to 
Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or the Agency) Center 
for Biologics Evaluation and Research (CBER), Office of Therapeutic 
Products (OTP) is announcing the Cellular and Gene Therapies 
Interactive Site Tours Program (the Interactive Site Tours Program). 
This program is

[[Page 57418]]

intended to give CBER regulatory project managers and/or reviewers an 
opportunity to tour biotechnology manufacturing facilities developing 
cellular and gene therapy products, and to exchange regulatory 
experiences with their industry counterparts. With this program, CBER 
intends to enhance review efficiency and quality by providing CBER 
staff with a better understanding of the biotechnology manufacturing 
industry and its operations. The purpose of this notice is to invite 
companies developing cellular and gene therapy products interested in 
participating in this program to contact OTP for more information.

DATES: Companies may send proposed agendas to the Agency by August 14, 
2024.

FOR FURTHER INFORMATION CONTACT: Lori Tull, Office of Review Management 
and Regulatory Review, Office of Therapeutic Products, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 240-
402-8361, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 351 of the Public Health Service Act (PHS Act), FDA 
is authorized to license biological products if they have been 
demonstrated to be ``safe, pure, and potent.'' CBER is one of two 
Centers at FDA that regulates biological products for human use under 
applicable statutory provisions of the PHS Act and the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). Section 3033 of the 21st Century 
Cures Act (Cures Act) (Pub. L. 114-255), was signed into law on 
December 13, 2016, and amended section 506 of the FD&C Act to 
specifically address the expedited development and review of certain 
regenerative medicine therapies, including cell therapies, therapeutic 
tissue engineering products, and human cell and tissue products.
    An important part of CBER's commitment to make safe and effective 
biological products available to all Americans is optimizing the 
efficiency and quality of the biologics review process. To support this 
goal, CBER has initiated various training and development programs to 
promote high performance in its regulatory project management and 
review staff. OTP seeks to enhance review efficiency and review quality 
by providing staff with a better understanding of the biotechnology 
industry and its operations. To this end, CBER/OTP is offering 
regulatory project managers and reviewers the opportunity to tour 
biotechnology manufacturing facilities. The goals are to provide the 
following: (1) firsthand exposure to industry's product development 
processes and (2) a venue for sharing information about project 
management best practices (but not product-specific information) with 
industry representatives.

II. The Interactive Site Tours Program

    In this program, which may last a few days, a small group of OTP 
regulatory project managers and/or reviewers, potentially also 
including senior level staff, can observe operations of biologics 
manufacturing and/or packaging facilities, pathology/toxicology 
laboratories, and regulatory affairs operations. Neither this tour nor 
any part of the program is intended as a mechanism to inspect, assess, 
judge, or perform a regulatory function, but is meant rather to provide 
an avenue for open dialogue between CBER/OTP staff and industry 
representatives. During the Interactive Site Tours Program, regulatory 
project managers and reviewers may also participate in daily workshops 
with their industry counterparts, focusing on selective regulatory 
issues important to both OTP staff and industry. The primary objective 
of the daily workshops is to understand the team approach to biological 
product development, including discovery, nonclinical and clinical 
evaluation, postmarketing activities, and regulatory submission 
operations. The overall benefit to regulatory project managers and 
reviewers will be exposure to project management, team techniques, and 
processes employed by the biotechnology industry. By participating in 
this program, the regulatory project managers and reviewers will gain a 
better understanding of industry processes and procedures.

III. Site Selection

    All travel expenses associated with the Interactive Site Tours 
Program will be the responsibility of OTP; therefore, selection of 
facility tour sites will be based on the availability of funds and 
resources for the program. Selection will also be based on firms having 
a favorable facility status as determined by FDA's Office of Regulatory 
Affairs District Offices in the firms' respective locations. Firm 
participation in the program is limited to companies developing 
cellular and/or gene therapy products. Firms that want to learn more 
about this opportunity or that are interested in offering a site tour 
should respond by sending a proposed agenda via email directly to Lori 
Tull (see DATES and FOR FURTHER INFORMATION CONTACT).

    Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15351 Filed 7-12-24; 8:45 am]
BILLING CODE 4164-01-P