[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34598-34599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12116]


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 DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Rapid Microbial Testing Methods Consortium

AGENCY: National Institute of Standards and Technology, Department of 
Commerce.

ACTION: Notice.

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SUMMARY: The National Institute of Standards and Technology (NIST), an 
agency of the United States Department of Commerce, in support of 
efforts to develop Standards for Regenerative Medicine and Advanced 
Therapies, is establishing the Rapid Microbial Testing Methods (RMTM) 
Consortium (``Consortium'') for developing standards, including 
reference materials, related to rapid microbial testing for 
regenerative medicine products. The Consortium efforts are intended to 
advance rapid microbial measurement capabilities, provide measurement 
assurance strategies, support the development of microbial reference 
material(s), and collect data to support the development of best 
practices and standard methods. Participants will be required to sign a 
Cooperative Research and Development Agreement (CRADA). There is no 
cost for participating in the consortium.

DATES: The Consortium's activities will commence on September 15, 2020 
(``Commencement Date''). NIST will accept letters of interest to 
participate in this Consortium on an ongoing basis. Acceptance of 
participants into the Consortium after the Commencement Date will 
depend on the availability of NIST resources.

ADDRESSES: Completed letters of interest or requests for additional 
information about the NIST RMTM Consortium can be directed via mail to 
Dr. Nancy Lin, Biosystems and Biomaterials Division of NIST's Material 
Measurement Laboratory, 100 Bureau Drive, Mail Stop 8543, Gaithersburg, 
Maryland 20899, or via electronic mail to [email protected], or by 
telephone at (301) 975-4935.

FOR FURTHER INFORMATION CONTACT: J'aime Maynard, CRADA Administrator, 
National Institute of Standards and Technology's Technology 
Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, 
Gaithersburg, Maryland 20899, by electronic mail to 
[email protected], or by telephone at (301) 975-8408.

SUPPLEMENTARY INFORMATION: The safety and quality of advanced therapies 
for regenerative medicine, including cell therapy, gene therapy, and 
tissue

[[Page 34599]]

engineered products, must be maintained prior to patient 
administration. The culture-based compendial methods currently used to 
assess product purity (specifically to ensure absence of microbial 
contamination) typically take weeks, which is inadequate for patients 
in urgent need of life-saving therapies. These methods are also 
incompatible with products that have a limited shelf-life and cannot 
meet good manufacturing practices required in process control and 
release testing. Alternative rapid microbial testing methods are needed 
to ensure fit for purpose safety assessments for this broad class of 
advanced therapeutics.
    NIST is establishing the RMTM Consortium to address this need. The 
Consortium's purpose is to develop solutions and standards to support 
the use of rapid microbial testing methods for regenerative medicine 
products. The Consortium efforts will focus on the following areas:

(1) Repository of Relevant Microorganisms

    NIST intends to establish a repository of microorganisms relevant 
to regenerative medicine product contamination, including contaminants 
found in products, in manufacturing environments, and other relevant 
microorganisms. Sets of microorganisms from the repository will be 
selected for interlaboratory studies and for incorporation into a 
candidate reference material, based on input from the Consortium. The 
reference material will be designed to increase confidence in the use 
of RMTMs and is expected to consist of multiple microorganisms. There 
will be opportunities for Consortium members to contribute relevant 
microorganisms to the repository.

(2) Rapid Microbial Testing Methods

    The NIST RMTM Consortium intends to develop an inventory of 
potential measurement methods and protocols for rapid microbial testing 
of regenerative medicine products. This inventory will include 
molecular methods and protocols that have been adopted successfully for 
rapid microbial detection as well as considerations for implementing 
test methods and approaches to validate protocols.

(3) Interlaboratory Studies

    The NIST RMTM Consortium intends to organize at least one 
interlaboratory study based on candidate reference materials with the 
goal of utilizing a common material to collect reproducible data on 
rapid microbial testing methods in support of measurement assurance and 
standards development.
    There is no cost for participating in the consortium.
    Process: Interested parties with relevant rapid microbial testing 
associated capabilities (see below), products, and/or technical 
expertise to support this Consortium should contact NIST using the 
information provided in the ADDRESSES section of this notice. NIST will 
then provide each interested party with a letter of interest template, 
which the party must complete and submit to NIST. NIST will contact 
interested parties if there are questions regarding the responsiveness 
of the letters. NIST will select participants who have submitted 
complete letters of interest based on the capabilities listed below. 
Eligibility will be determined solely by NIST based on information 
provided by interested parties and upon the availability of necessary 
resources to NIST.
    To participate in the NIST RMTM Consortium, the eligible applicant 
will be required to sign a CRADA with NIST.
    Requirements: Each letter of interest should provide the following 
information:
    (1) A description of the experience in development or use of rapid 
microbial testing methods or production of regenerative medicine 
products or related expertise.
    (2) Topic areas of interest for participation.
    (3) List of interested party's anticipated participants.
    Letters of interest may not include business proprietary 
information. NIST will not treat any information provided in response 
to this Notice as proprietary information. NIST will notify each 
organization of its eligibility. NIST does not guarantee participation 
in the Consortium to any organization submitting a letter of interest.

    Authority:  15 U.S.C. 272; 21 U.S.C. 356g.

Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2020-12116 Filed 6-4-20; 8:45 am]
 BILLING CODE 3510-13-P