Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices 71003 

16https://www.trade.gov/consolidated-screeninglist. 

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. 

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 

• 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 

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), ezinne.ebi@hhs.gov, (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 

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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