Form 0920-XXXX Attestation Form

Form Approved

OMB Control No: 0920-xxxx

Exp. Date: X/XX/XXXX

Public reporting burden of this collection of information is estimated at 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/Information Collection Review Office, 1600 Clifton Road, NE, MS H21-8, Atlanta, GA 30333; Attn: PRA (0920-xxxx).

Read all instructions before completing this attestation form

Purpose: The purpose of this form is to assist Providers of synthetic nucleic acids¹ (Providers) and Manufacturers of benchtop nucleic acid synthesis equipment² (Manufacturers) in making an attestation that they are adhering to the 2024 Office of Science and Technology Policy (OSTP) Framework for Nucleic Acid Synthesis Screening (Framework).³ While Providers and Manufacturers may choose a different mode to make such an attestation, this form is an acceptable template. Through the attestation process, Providers and Manufacturers indicate to the U.S. Federal Government — and to researchers using any United States Government life sciences research award (e.g., research grant, contract, etc.) for procurement of synthetic nucleic acids or benchtop nucleic acid synthesis equipment —that they adhere to the Framework.

Background: This attestation form was developed pursuant to the Framework, which was released by OSTP in April of 2024. The Framework was directed by Executive Order 14110, “Safe, Secure, and Trustworthy Development of Artificial Intelligence” (Oct. 30, 2023).⁴ The Framework recommends that Providers and Manufacturers:

1. Attest to implementing this screening framework through a statement that either is posted on a public website or provided to the federally funded customer and federal funding agency upon request;

2. Screen purchase orders for synthetic nucleic acids to identify sequences of concern (SOCs);

3. Perform “know your customer” practices and screen customers submitting purchase orders of synthetic nucleic acids with SOCs, and purchase orders of benchtop nucleic acid synthesis equipment, to verify legitimacy;

4. Report potentially illegitimate purchase orders of synthetic nucleic acids involving SOCs or of benchtop nucleic acid synthesis equipment;

5. Retain records relating to purchase orders for synthetic nucleic acids and benchtop nucleic acid synthesis equipment; and

6. Take steps to ensure cybersecurity and information security.

Entities that may complete this attestation: Providers and Manufacturers who wish to sell synthetic nucleic acids or benchtop nucleic acid synthesis equipment to the federal government or to researchers using federal funds should either complete this form or make an equivalent statement of attestation.

Filling Out the Attestation: Providers and Manufacturers should either post this form on a public website or make it available to customers procuring synthetic nucleic acids or benchtop nucleic acid synthesis equipment with federal funds and federal funding agencies upon request. For this form to remain valid, Providers and Manufacturers should update their attestations by January 1^st of each year to ensure that they are providing the most up-to-date information, or more frequently if point-of-contact information changes. The form collects contact and basic information from Providers and Manufacturers. The attestation lists five minimum requirements that are derived from the Framework. Providers and Manufacturers should review the Framework in detail in advance of completing this attestation.

The form should be signed by an individual with the authority to respond on behalf of the organization. Incomplete attestation forms should be deemed non-compliant with the attestation requirements of the Framework.

The attestation form and instructions are subject to change.

ATTESTATION FORM

Section I – Attestation Type

• New Attestation [IF APPLICABLE] Organizational Persistent Identifier (PID): ___________

• Revised or Updated Attestation

Section II – Contact Information

Organization

Organization Name: ______________ Organization Website: ________________

Address: _______________________ Organization Type: ___________________

City: __________________________ (e.g., Academic, Private, Governmental)

State/Province: _________________

Country: _______________________

Primary Contact

Name and Title: __________________ Phone Number: _______________________

Address: ________________________ Email Address: ________________________

Secondary Contact

Name and Title: __________________ Phone Number: _______________________

Address: ________________________ Email Address: ________________________

Section III – Attestation and Signature

On behalf of the above organization, I attest that, to the best of my knowledge, [ORGANIZATION NAME] adheres to the Framework for Nucleic Acid Synthesis Screening (“the Framework”).⁵ Specifically, [ORGANIZATION NAME] implements the following minimum actions:

[IF THE COMPANY SELLS SYNTHETIC NUCLEIC ACID SEQUENCES DIRECTLY TO CUSTOMERS]

1. Screen purchase orders for synthetic nucleic acid sequences to identify sequences of concern (SOCs) consistent with the Framework.⁶

2. Follow “Know Your Customer” practices outlined in the Framework and verify the legitimacy of customers and institutions submitting purchase orders of synthetic nucleic acids with SOCs, consistent with the Framework.

3. Report potentially illegitimate purchase orders of synthetic nucleic acids involving SOCs to the Federal Bureau of Investigation or Department of Commerce as explained in the Framework.

4. Retain a record of purchase orders for synthetic nucleic acids for at least 3 years, as explained in the Framework.

5. Takes steps to ensure cyber and information security of the organization’s data, consistent with the Framework.

[IF THE COMPANY SELLS BENCHTOP NUCLEIC ACID SYNTHESIS EQUIPMENT DIRECTLY TO CUSTOMERS]

1. Follow “Know Your Customer” practices outlined in the Framework and verify the legitimacy of customers and institutions submitting purchase orders of benchtop nucleic acid synthesis equipment, consistent with the Framework.

2. Report potentially illegitimate purchase orders of benchtop nucleic acid synthesis equipment to the Federal Bureau of Investigation or Department of Commerce, as explained in the Framework.

3. Retain a record of purchase orders for benchtop nucleic acid synthesis equipment for at least 3 years, as explained in the Framework.

4. Takes steps to ensure cyber and information security of the organization’s data, consistent with the Framework.

[ORGANIZATION NAME] will publish on a public website and notify any customers and federal funding agencies to which [ORGANIZATION NAME] has previously submitted this form within 72 hours if the organization ceases to make consistent use of any of practices identified above.

Signature of individual with authority to speak on behalf of [ORGANIZATION NAME] :

___________________________________________________________

Date (yyyy-mm-dd): _______________________________

Location: ________________________________________

Name and Title: ___________________________________

Position within the organization: _____________________

1 Providers are defined as an entity that synthesizes and distributes synthetic nucleic acids. Providers may provide nucleic acids to a customer or third-party vendor. A Provider is understood to be synthesizing and distributing nucleic acids as a transactional service, rather than as a research scientist collaborating with a colleague.

2 Manufacturers are defined as an entity that produces and distributes benchtop equipment for synthesizing nucleic acids. Manufacturers may provide equipment to a customer or third party vendor.

3 https://www.whitehouse.gov/wp-content/uploads/2024/04/Nucleic-Acid_Synthesis_Screening_Framework.pdf

4 https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence

5 https://www.whitehouse.gov/wp-content/uploads/2024/04/Nucleic-Acid_Synthesis_Screening_Framework.pdf

6 SOC is defined at the time of the Framework’s issuance as a nucleotide sequence or its corresponding amino acid sequence that is a Best Match to a sequence of federally regulated agents (i.e., the Biological Select Agents and Toxins List (BSAT), or the Commerce Control List (CCL)), except when the sequence is also found in an unregulated organism or toxin. As of and after October 13, 2026, this definition will include sequences known to contribute to pathogenicity or toxicity, even when not derived from or encoding regulated biological agents.