Compliance Attestation Statement for the Framework for Nucleic Acid Synthesis Screening

Forms and Documents

Document Name	Status
Form 0920-XXXX Synthetic Nucleic Acids Providers/Manufacturers - Attestation Form Form and Instruction	New
SSB - SynNA attestation letter_v2.docx Supporting Statement B	2024-09-24
SSA - SynNA attestation letter_FINAL.docx Supporting Statement A	2024-09-24
60d FRN - published.pdf Supplementary Document	2024-09-18

IC Document Collections

IC ID	Document Title	Status
271044	Synthetic Nucleic Acids Providers/Manufacturers - Attestation Form Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202409-0920-015
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24HP
Title: Compliance Attestation Statement for the Framework for Nucleic Acid Synthesis Screening
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  Yes
Type of Review Request: Regular	Date Submitted to OIRA: 09/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	60	0
Time Burden (Hours)	20	0
Cost Burden (Dollars)	0	0

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Abstract: Project is designed to assist providers and manufacturers of synthetic nucleic acids and benchtop nucleic acid synthesis equipment in making an attestation that they have instituted a process to screen nucleic acid sequences of concern and verify customer legitimacy, in accordance with the requirements outlaid in the OSTP Framework for Nucleic Acid Synthesis Screening.

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Authorizing Statute(s): EO: EO 14110 Name/Subject of EO: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 59916	07/24/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 78874	09/26/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Synthetic Nucleic Acids Providers/Manufacturers - Attestation Form	0920-XXXX	Attestation Form

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	60	0	0	60	0	0
Annual Time Burden (Hours)	20	0	0	20	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Submission of 0920-24HP is a New ICR (on behalf of NSC/OSTP).

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Annual Cost to Federal Government: $4,881

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  Yes

Description/Changes for Common Form Usage:  CDC seeks approval of a data collection titled Workplan Template for Self-Attestation Statement for the Framework for Nucleic Acid Synthesis Screening. The associated form will be used by NSC/OSTP to assist providers and manufacturers of synthetic nucleic acids and benchtop nucleic acid synthesis equipment in making an attestation that they have instituted a process to screen nucleic acid sequences of concern.

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/26/2024

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