federal_register: 2010-25728
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
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| 2010-25728 | Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA | Notice | To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding Select Agents or Toxins and, as applicable, agents on the Export Administration Regulations' (EAR's) Commerce Control List (CCL), the U.S. Government has developed Guidance that provides a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (the Guidance), sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products regarding the screening of orders so that they are filled in compliance with current U.S. regulations and to encourage best practices in addressing biosecurity concerns associated with the potential misuse of their products to bypass existing regulatory controls. Following this Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations. The framework includes customer screening and sequence screening, follow-up screening as necessary, and consultation with U.S. Government contacts, as needed. A draft version of the Guidance was published as a Federal Register Notice (Federal Register, Vol. 74, No. 227, November 27, 2009, Screening Framework Guidance for Synthetic Double-Stranded DNA Providers) for public consideration and comment for a period of 60 days. Comments were reviewed and the Guidance was amended through a deliberative interagency process. The Response to Public Comments document, which precedes the final Guidance in the Supplementary Information section of this Notice, provides a general review of the decisions made to alter the Guidance in response to public comments. The Department of Health and Human Services (HHS) is issuing this document as the lead agency in a broad interagency process to draft the Guidance. The Guidance will be reviewed on a regular basis and revised, as necessary. For further details about the Guidance, to access public comments, and to provide ongoing feedback please refer to http:// www.phe.gov/preparedness/legal/guidance/syndna. | 2010-10-13 | 2010 | 10 | https://www.federalregister.gov/documents/2010/10/13/2010-25728/screening-framework-guidance-for-providers-of-synthetic-double-stranded-dna | https://www.govinfo.gov/content/pkg/FR-2010-10-13/pdf/2010-25728.pdf | Health and Human Services Department | 221 | To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding Select Agents or Toxins and, as applicable, agents on the Export Administration... |