Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids
As published in the Federal Register of 13 October 2023 (88 FR 70998). Federal Register issue date of the notice. The notice states no separate effective date, unlike the 2010 guidance.
- Issued by
- Administration for Strategic Preparedness and Response (U.S. Department of Health and Human Services)
- Authors credited
- No authorship claim recorded yet. The source record lists Federal Register (Office of the Federal Register, National Archives) via govinfo.gov.
- Dates
- Published 2023-10-13 issue evidence
Federal Register issue date of the notice. The notice states no separate effective date, unlike the 2010 guidance. The version family is recorded under the Department, which issues these notices; the component named in each notice is recorded by the publication record.
- Exact source
- Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (88 FR 70998) Federal Register (Office of the Federal Register, National Archives) via govinfo.gov · publication date unknown · Retrieved for the candidate pack on 2026-10-28 (SHA-256 20a3b9081d675539a0d8991d9021e5216ec373da9750df8711a4b55a47d54f16). Federal Register print of 13 October 2023, Vol. 88, No. 197, pp. 70998-71004, FR Doc. 2023-22540. The notice publishes the Guidance in full. Its technical sections (sequence screening methodology and the definitions that state screening criteria) were read but are not cited. Retrieved again at admission on 2026-10-30 (SHA-256 20a3b9081d675539a0d8991d9021e5216ec373da9750df8711a4b55a47d54f16, the same bytes).
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Versions
us-hhs-synthetic-nucleic-acid-screening-guidance: 3 recorded versions, oldest first, published by United States Department of Health and Human Services. A version is shown as replacing another only where a record says so. Date order alone never implies it.
- 2010-10-13 · effectiveAs published in the Federal Register of 13 October 2010 (75 FR 62820)
- 2022-04-29 · publishedAs published in the Federal Register of 29 April 2022 (87 FR 25495)
- 2023-10-13 · publishedAs published in the Federal Register of 13 October 2023 (88 FR 70998) (this version)
This version
- ReplacesThe 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids states that advances in the field motivated the United States Government to review and revise the 2010 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, and cites the 2010 guidance at 75 FR 62820.2023-10-13 · publication · Stated in source · Supported Inspect claim & evidence ↗Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA: document page →
Provisions in this version · 4 quoted
A limited selection of quoted provisions: what this edition says about thresholds, required actions, who decides and exceptions, and other statements of the text. It is not a full summary and says nothing about implementation. A “not found” record states which part of the edition was inspected. It is not a claim that the text was deleted.
- Threshold or triggerScope: all types of synthetic nucleic acids, and the categories of entity addressed“The Guidance pertains to the sale or transfer of all types of synthetic nucleic acids, i.e., DNA and RNA, whether single- or double-stranded.”III. Goals and Scope of the Guidance, 88 FR 71000Inspect claim & evidence ↗
- Required actionRecommended actions for manufacturers of benchtop nucleic acid synthesis equipment“Manufacturers should screen all Customers purchasing benchtop nucleic acid synthesizers to validate customer legitimacy and that the equipment is appropriate for their needs.”IV. Best practices for benchtop equipment, first bullet, 88 FR 71001Inspect claim & evidence ↗
- Required actionRecommended provider actions on receiving an order: sequence screening, customer identity verification and follow-up“upon receiving an order for synthetic nucleic acids, Providers and Third-Party Vendors perform sequence screening, verify the identity of their Customers, and follow up to verify the legitimacy of the order when SOCs are identified”I. Introduction, recommendation (1), 88 FR 70999Inspect claim & evidence ↗
- Required actionRecommended action where concerns are not resolved: do not fulfil the order and contact designated government entities“Providers should not fulfill the order and should contact designated entities within the U.S. government”I. Introduction, 88 FR 71000Inspect claim & evidence ↗
Coverage gap. No change from the previous edition is recorded yet. That does not mean nothing changed.
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