Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting, 34599 [2020-12214]
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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.
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(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
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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
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[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Page 34599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12214]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
[RTID 0648-XA202]
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Notice; public meeting.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: The meeting will be held on Tuesday, June 23, 2020, from 9 a.m.
to 12 p.m. For agenda details, see SUPPLEMENTARY INFORMATION.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT: Christopher M. Moore, Ph.D., Executive
Director, Mid-Atlantic Fishery Management Council, telephone: (302)
526-5255.
SUPPLEMENTARY INFORMATION: 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.
Special Accommodations
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
