{"entities":[{"id":"us-hhs-synthetic-dsdna-guidance-2010","name":"Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA"},{"id":"us-hhs-synthetic-nucleic-acids-guidance-2023","name":"Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids","subtype":"Guidance","description":"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.","sourceIds":["source-ab-hhs-2023-fr"]},{"id":"us-hhs","name":"United States Department of Health and Human Services"},{"id":"us-aspr","name":"Administration for Strategic Preparedness and Response (U.S. Department of Health and Human Services)"}],"claims":[{"id":"ab-scr-hhs-2010-all-providers-addressees","attributes":{"provision":{"kind":"threshold","key":"us-hhs-screening-guidance-2010-addressees"}}},{"id":"ab-scr-hhs-2010-effective-date","attributes":{"provision":{"kind":"date","key":"hhs-2010-effective-date"}}},{"id":"ab-scr-hhs-2010-voluntary-all-providers","attributes":{"provision":{"kind":"standing","key":"us-hhs-screening-guidance-2010-voluntary-standing"}}},{"id":"ab-scr-hhs-2023-benchtop-manufacturers","statement":"The 2023 Guidance recommends that manufacturers of benchtop nucleic acid synthesis equipment screen all customers purchasing such equipment to validate customer legitimacy, provide equipment only to customers with mechanisms to ensure that devices are operated by legitimate users, and integrate into the equipment the capability to screen sequences and to authenticate legitimate users.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2023-benchtop-manufacturers-1","evidence-ab-scr-hhs-2023-benchtop-manufacturers-2"],"attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-benchtop-manufacturers"}}},{"id":"ab-scr-hhs-2023-provider-screening","statement":"The 2023 Guidance recommends that, 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 sequences in the Guidance's category of concern are identified.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2023-provider-screening-1"],"attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-provider-order-screening"}}},{"id":"ab-scr-hhs-2023-published","statement":"The Administration for Strategic Preparedness and Response published the Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids in the Federal Register of 13 October 2023, stating that it sets out baseline standards for the gene and genome synthesis industry and best practices for all entities involved in the provision, use and transfer of synthetic nucleic acids.","derivation":"explicit","resolution":"supported","editorialState":"seed","evidenceIds":["evidence-ab-scr-hhs-2023-published-1"]},{"id":"ab-scr-hhs-2023-refuse-and-report","statement":"The 2023 Guidance recommends that, where follow-up screening does not resolve concerns about an order or there is reason to believe a customer may violate United States laws or regulations, providers should not fulfil the order and should contact designated entities within the United States Government, which it identifies as the Department of Commerce and the Federal Bureau of Investigation.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2023-refuse-and-report-1"],"attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-refusal-and-reporting"}}},{"id":"ab-scr-hhs-2023-scope","statement":"The 2023 Guidance states that it pertains to the sale or transfer of all types of synthetic nucleic acids, DNA and RNA and single- or double-stranded, and that it sets recommended baseline standards for providers and for manufacturers of benchtop nucleic acid synthesis devices and best practices for customers, including institutions, principal users, end users and third-party vendors.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2023-scope-1","evidence-ab-scr-hhs-2023-scope-2"],"attributes":{"provision":{"kind":"threshold","key":"us-hhs-screening-guidance-2023-scope"}}},{"id":"ab-scr-hhs-2023-supersedes-2010","statement":"The 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.","derivation":"explicit","resolution":"supported","editorialState":"seed","evidenceIds":["evidence-ab-scr-hhs-2023-supersedes-2010-1"]}],"sources":[{"id":"source-ab-hhs-2023-fr","title":"Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (88 FR 70998)","authors":["Federal Register (Office of the Federal Register, National Archives) via govinfo.gov"],"publisher":"Federal Register (Office of the Federal Register, National Archives) via govinfo.gov","publicationDate":null,"version":"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).","evidenceUrl":"https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/2023-22540.pdf","language":"en"}],"evidence":[{"id":"evidence-ab-scr-hhs-2023-benchtop-manufacturers-1","support":"supports","locator":"IV. Best practices for benchtop equipment, first bullet, 88 FR 71001","passage":"Manufacturers should screen all Customers purchasing benchtop nucleic acid synthesizers to validate customer legitimacy and that the equipment is appropriate for their needs.","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2023-provider-screening-1","support":"supports","locator":"I. Introduction, recommendation (1), 88 FR 70999","passage":"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","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2023-published-1","sourceRole":"primary","support":"supports","verification":"machine_checked","retrievalRoute":"direct"},{"id":"evidence-ab-scr-hhs-2023-refuse-and-report-1","support":"supports","locator":"I. Introduction, 88 FR 71000","passage":"Providers should not fulfill the order and should contact designated entities within the U.S. government","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2023-scope-1","support":"supports","locator":"III. Goals and Scope of the Guidance, 88 FR 71000","passage":"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.","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2023-supersedes-2010-1","sourceRole":"primary","support":"supports","verification":"machine_checked","retrievalRoute":"direct"}],"at":{"entities":[1215,1216,1224,1225],"claims":[3282,3283,3285,3293,3294,3295,3296,3297,3298],"sources":[1046],"evidence":[4516,4518,4519,4520,4521,4523]},"version":"1lg47t7"}