Rapid Microbial Testing Methods Consortium, 34598-34599 [2020-12116]

Download as PDF 34598 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended. Please follow the requirements set forth in EDA’s regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms. Miriam Kearse, Lead Program Analyst. [FR Doc. 2020–12240 Filed 6–4–20; 8:45 am] BILLING CODE 3510–WH–P DEPARTMENT OF COMMERCE National Telecommunications and Information Administration First Responder Network Authority Public Combined Board and Board Committees Meeting First Responder Network Authority (FirstNet Authority), National Telecommunications and Information Administration (NTIA), U.S. Department of Commerce. ACTION: Announcement of meeting. AGENCY: The FirstNet Authority Board will convene an open public meeting of the Board and the four (4) Board Committees, Governance and Personnel, Network and Technology, Advocacy, and Finance Committees. DATES: June 17, 2020; 11:00 a.m. to 1:00 p.m. Eastern Standard Time (EST); WebEx. SUMMARY: The public meeting will be conducted via teleconference and WebEx only. Members of the public may listen to the meeting by dialing toll-free: 1–888–982–7296 and enter participant code 3161488#. If you experience technical difficulty, please contact the Conferencing Center Customer Service at: 1–866–900–1011. To view the slide presentation, the public may visit the URL: https://www.mymeetings.com/nc/ join/ and enter Conference Number: PWXW9653105 and Audience Passcode: 3161488. Alternatively, members of the public may view the slide presentation lotter on DSK9F5VC42PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 by directly visiting the URL: https:// www.mymeetings.com/nc/join.php?i =PWXW9653105&p=3161488&t=c. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF COMMERCE National Institute of Standards and Technology For general information: Janell Smith, (202) 257–5929, Janell.Smith@ FirstNet.gov. For media inquiries: Ryan Oremland, (571) 665–6186, Ryan.Oremland@ FirstNet.gov. Rapid Microbial Testing Methods Consortium SUPPLEMENTARY INFORMATION: SUMMARY: Background: The Middle Class Tax Relief and Job Creation Act of 2012 (codified at 47 U.S.C. 1401 et seq.) (Act) established the FirstNet Authority as an independent authority within NTIA. The Act directs the FirstNet Authority to ensure the building, deployment, and operation of a nationwide interoperable public safety broadband network. The FirstNet Authority Board is responsible for making strategic decisions regarding the FirstNet Authority’s operations. Matters to be Considered: The FirstNet Authority will post a detailed agenda for the Combined Board and Board Committees Meeting on FirstNet.gov prior to the meeting. The agenda topics are subject to change. Please note that the subjects discussed by the Board and Committees may involve commercial or financial information that is privileged or confidential, or other legal matters affecting the FirstNet Authority. As such, the Board and Committee Chairs may call for a vote to close the meetings only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2). Other Information: The public Combined Board and Board Committees meeting are accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Ms. Smith at (202) 257– 5929 or email: Janell.Smith@ FirstNet.gov at least five (5) business days (June 9) before the meeting. Records: The FirstNet Authority maintains records of all Board proceedings. Minutes of the Board and Committee meetings will be available on FirstNet.gov. Dated: June 1, 2020. Janell Smith, Board Secretary, First Responder Network Authority. [FR Doc. 2020–12187 Filed 6–4–20; 8:45 am] BILLING CODE 3510–TL–P PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 National Institute of Standards and Technology, Department of Commerce. ACTION: Notice. AGENCY: 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 rmtm@nist.gov, 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 Jaime.maynard@nist.gov, 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 E:\FR\FM\05JNN1.SGM 05JNN1 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices 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 shelflife 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. lotter on DSK9F5VC42PROD with NOTICES (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 VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 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. BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration [RTID 0648–XA202] Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting National Marine Fisheries Service (NMFS), National Oceanic and AGENCY: Frm 00011 Fmt 4703 Atmospheric Administration (NOAA), Commerce. ACTION: Notice; public meeting. The Mid-Atlantic Fishery Management Council’s (MAFMC) Bluefish Advisory Panel will hold a public meeting, jointly with the Atlantic States Marine Fisheries Commission (ASMFC) Bluefish Advisory Panel. SUMMARY: The meeting will be held on Tuesday, June 23, 2020, from 9 a.m. to 12 p.m. For agenda details, see SUPPLEMENTARY INFORMATION. DATES: The meeting will be held via webinar with a telephone-only connection option. Details on the proposed agenda, webinar listen-in access, and briefing materials will be posted at the MAFMC’s website: www.mafmc.org. Council address: Mid-Atlantic Fishery Management Council, 800 N State Street, Suite 201, Dover, DE 19901; telephone: (302) 674–2331 or on their website at www.mafmc.org. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526–5255. The purpose of this meeting is for the Advisory Panel to develop a fishery performance report (FPR) and comment on draft alternatives for the Bluefish Allocation and Rebuilding Amendment. The intent of the FPR is to facilitate a venue for structured input from the Advisory Panel for the bluefish specifications process. The FPR will be used by the MAFMC’s Scientific and Statistical Committee (SSC) and the Bluefish Monitoring Committee (MC) when reviewing 2021 management measures designed to achieve the recommended bluefish catch and landings limits. SUPPLEMENTARY INFORMATION: Special Accommodations [FR Doc. 2020–12116 Filed 6–4–20; 8:45 am] PO 00000 34599 Sfmt 9990 The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526–5251, at least 5 days prior to the meeting date. Authority: 16 U.S.C. 1801 et seq. Dated: June 2, 2020. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2020–12214 Filed 6–4–20; 8:45 am] BILLING CODE 3510–22–P E:\FR\FM\05JNN1.SGM 05JNN1

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[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]


-----------------------------------------------------------------------

 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.

-----------------------------------------------------------------------

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