{"entities":[{"id":"us-hhs-synthetic-dsdna-guidance-2010","name":"Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA","subtype":"Guidance","description":"As published in the Federal Register of 13 October 2010 (75 FR 62820). Both dates from the notice: the Federal Register issue of 13 October 2010 and the notice's DATES caption, which states the same day as the effective date.","sourceIds":["source-ab-hhs-2010-fr"]},{"id":"us-hhs-synthetic-nucleic-acids-guidance-2023","name":"Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids"},{"id":"us-hhs","name":"United States Department of Health and Human Services"}],"claims":[{"id":"ab-scr-hhs-2010-all-providers-addressees","statement":"The 2010 notice states that the final Guidance is directed to all providers of synthetic double-stranded DNA, the recommendations of the draft Guidance having been directed to 'commercial' providers.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2010-all-providers-addressees-1"],"attributes":{"provision":{"kind":"threshold","key":"us-hhs-screening-guidance-2010-addressees"}}},{"id":"ab-scr-hhs-2010-effective-date","statement":"The 2010 notice states that the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA is effective on 13 October 2010.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2010-effective-date-1"],"attributes":{"provision":{"kind":"date","key":"hhs-2010-effective-date"}}},{"id":"ab-scr-hhs-2010-published","statement":"The United States Department of Health and Human Services, through its Office of the Secretary, published the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA in the Federal Register of 13 October 2010, stating that it sets out recommended baseline standards for the gene and genome synthesis industry and other providers regarding the screening of orders.","derivation":"explicit","resolution":"supported","editorialState":"seed","evidenceIds":["evidence-ab-scr-hhs-2010-published-1"]},{"id":"ab-scr-hhs-2010-voluntary-all-providers","statement":"The 2010 Guidance states that following it is voluntary, though many of its specific recommendations serve to remind providers of their obligations under existing regulations.","resolution":"supported","evidenceIds":["evidence-ab-scr-hhs-2010-voluntary-all-providers-1"],"attributes":{"provision":{"kind":"standing","key":"us-hhs-screening-guidance-2010-voluntary-standing"}}},{"id":"ab-scr-hhs-2023-benchtop-manufacturers","attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-benchtop-manufacturers"}}},{"id":"ab-scr-hhs-2023-provider-screening","attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-provider-order-screening"}}},{"id":"ab-scr-hhs-2023-refuse-and-report","attributes":{"provision":{"kind":"required_action","key":"us-hhs-screening-guidance-2023-refusal-and-reporting"}}},{"id":"ab-scr-hhs-2023-scope","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-2010-fr","title":"Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (75 FR 62820)","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 d3bfd95a1e3ae4d212505081166f0f8bb7475845e225ae643e6d4a03a93b7e56). Federal Register print of 13 October 2010, Vol. 75, No. 197, pp. 62820-62832, FR Doc. 2010-25728. The notice publishes the final Guidance in full, after the comment responses. Retrieved again at admission on 2026-10-30 (SHA-256 d3bfd95a1e3ae4d212505081166f0f8bb7475845e225ae643e6d4a03a93b7e56, the same bytes).","evidenceUrl":"https://www.govinfo.gov/content/pkg/FR-2010-10-13/pdf/2010-25728.pdf","language":"en"}],"evidence":[{"id":"evidence-ab-scr-hhs-2010-all-providers-addressees-1","support":"supports","locator":"Response to comments on scope, 75 FR 62823","passage":"the final Guidance is directed to all providers of synthetic dsDNA","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2010-effective-date-1","support":"supports","locator":"DATES, 75 FR 62820","passage":"The Guidance is effective on October 13, 2010.","passageType":"quote"},{"id":"evidence-ab-scr-hhs-2010-published-1","sourceRole":"primary","support":"supports","verification":"machine_checked","retrievalRoute":"direct"},{"id":"evidence-ab-scr-hhs-2010-voluntary-all-providers-1","support":"supports","locator":"SUMMARY, 75 FR 62820","passage":"Following this Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations.","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],"claims":[3282,3283,3284,3285,3293,3294,3296,3297,3298],"sources":[1044],"evidence":[4499,4500,4501,4502,4523]},"version":"1lg47t7"}