Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry
| Published date | 15 July 2024 |
| Record Number | 2024-15351 |
| Citation | 89 FR 57417 |
| Court | Food And Drug Administration |
| Section | Notices |
Federal Register, Volume 89 Issue 135 (Monday, July 15, 2024)
[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
