Biomedical Advanced Research and Development Authority Industry Day 2023, 71003 [2023-22539]
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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
items.16 In the event that a company,
entity, or person on the list appears to
match that of a customer or other
recipient, additional due diligence
should be conducted before proceeding.
There may be a strict export prohibition,
a requirement for seeking a license
application, or other evaluation of the
Customer or other recipient necessary to
ensure it does not result in an activity
prohibited by any U.S. export
regulations, or other restrictions. Before
fulfilling the order, to ensure full
compliance with all the terms and
conditions of the restrictions placed on
the parties on this list, the Provider
must check the official publication of
restricted parties in the Federal
Register.
VII. Following Up With the U.S.
Government in Cases Where Malintent
is Suspected by Providers, Third-Party
Vendors, or Manufacturers
If sequence or Customer screening
raises concerns that are not alleviated
through follow-up screening, Providers,
Third-Party Vendors, and Manufacturers
should not fulfill the order and are
strongly encouraged to contact their
nearest FBI Field Office’s WMD
Coordinator. Institutions are encouraged
to work with their Principal Users and
End Users to help them understand that
only individuals with legitimate, bona
fide, and peaceful purpose should
obtain synthetic nucleic acids
containing SOCs.
lotter on DSK11XQN23PROD with NOTICES1
VIII. Records Retention
The Guidance recommends that
Providers, Third-Party Vendors, and
Manufacturers retain the following
types of records for at least three years,
and longer (e.g., eight years) if this does
not pose an undue burden on their
operations:
• Records of Customer orders
including the following information:
Customer information (point-of contact
name, organization, address, email, and
phone number), order sequence
information (nucleotide sequences
ordered, vector used), and order
information (date placed and shipped,
shipping address, receiver name);
• Records of protocols for sequence
screening and for determining whether
a sequence hit qualifies as a SOC;
• Records of screening
documentation of all hits, even if the
order was deemed acceptable;
• Records of any follow-up screening,
even if the order was ultimately filled;
and
16 https://www.trade.gov/consolidated-screening-
list.
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• The ultimate disposition of any
SOC orders, with documentation of
reasoning for final decision (fulfill
versus deny).
IX. Periodic Review, Evaluation, and
Improvement of This Guidance
This Guidance addresses biosecurity
risks that have emerged in a dynamic
and rapidly developing technological
landscape. It is likely that new risks will
emerge and that new technological
approaches will also appear to address
them. As such, this Guidance
encourages the further development of
mechanisms to detect SOCs and
screening strategies for sequences that
contribute directly to pathogenicity and
toxicity. For instance, strategies may be
used by malicious Customers to
obfuscate SOCs, including engineering
pathogenic or toxic proteins with
completely novel sequences. In such
cases, synthetic nucleic acid orders may
contain 50 nt windows that are not a
match to any known sequence.
Although there are likely legitimate
explanations for orders of sequences
with no matches in existing databases
(e.g., nucleic acids ordered to populate
microarrays or to store digital
information), in such cases, it may be
possible to use predictive bioinformatic
algorithms to screen sequences that are
not a match to any known sequences to
determine if they could produce
proteins that are structurally and
functionally identical to SOCs. This
Guidance encourages Providers to
continue to develop these methods to
best ensure the safety and security of the
synthetic nucleic acid research
enterprise.
This Guidance will be periodically
revisited, including by soliciting
stakeholder input, and feedback is
encouraged from the nucleic acid
synthesis industry as well as from their
customers as they implement the
Guidance. Furthermore, implementation
of this Guidance will be supported
through the publication of a Companion
Guide.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2023–22540 Filed 10–12–23; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Biomedical Advanced Research and
Development Authority Industry Day
2023
Administration for Strategic
Preparedness and Response (ASPR),
AGENCY:
PO 00000
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71003
Department of Health and Human
Services (HHS).
ACTION: Notice.
The Biomedical Advanced
Research and Development Authority
(BARDA) annually hosts BARDA
Industry Day (BID), a two-day
conference with industry and our
government partners to share BARDA’s
goals and objectives, increase awareness
of U.S. government medical
countermeasure (MCM) priorities, and
facilitate collaboration between public
and private sectors within the health
security space. This year, BARDA plans
to discuss implementation efforts for
our 2022–2026 Strategic Plan, which
focuses on strengthening the health
security of the nation, embracing
lessons learned from the COVID–19
pandemic, incorporating new avenues
of promising research and development,
and addressing the imperative for
MCMs that are safe, effective, and
widely accessible.
DATES: BID 2023 will be a hybrid event,
held from Monday, November 13–
Tuesday, November 14, 2023. The
meeting will begin each day at 9 a.m.
Eastern Standard Time.
ADDRESSES: This meeting is open to the
public. Register here: https://
medicalcountermeasures.gov/barda/
barda-industry-day-2023/.
FOR FURTHER INFORMATION CONTACT:
Ezinne N. Ebi, Biomedical Advanced
Research & Development Authority
(BARDA), ezinne.ebi@hhs.gov, (202)
989–5539.
SUMMARY:
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2023–22539 Filed 10–12–23; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Biomedical Imaging and
Bioengineering.
The meeting will be open to the
public by videocast as indicated below.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
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]]>Agencies
[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Page 71003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22539]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Biomedical Advanced Research and Development Authority Industry
Day 2023
AGENCY: Administration for Strategic Preparedness and Response (ASPR),
Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Biomedical Advanced Research and Development Authority
(BARDA) annually hosts BARDA Industry Day (BID), a two-day conference
with industry and our government partners to share BARDA's goals and
objectives, increase awareness of U.S. government medical
countermeasure (MCM) priorities, and facilitate collaboration between
public and private sectors within the health security space. This year,
BARDA plans to discuss implementation efforts for our 2022-2026
Strategic Plan, which focuses on strengthening the health security of
the nation, embracing lessons learned from the COVID-19 pandemic,
incorporating new avenues of promising research and development, and
addressing the imperative for MCMs that are safe, effective, and widely
accessible.
DATES: BID 2023 will be a hybrid event, held from Monday, November 13-
Tuesday, November 14, 2023. The meeting will begin each day at 9 a.m.
Eastern Standard Time.
ADDRESSES: This meeting is open to the public. Register here: https://medicalcountermeasures.gov/barda/barda-industry-day-2023/.
FOR FURTHER INFORMATION CONTACT: Ezinne N. Ebi, Biomedical Advanced
Research & Development Authority (BARDA), [email protected], (202)
989-5539.
Dawn O'Connell,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2023-22539 Filed 10-12-23; 8:45 am]
BILLING CODE 4150-37-P
