Department of Health and Human Services September 13, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). Specifically, the guidance provides recommendations regarding the use of an FDA-licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. This guidance supplements the donor screening recommendations for WNV (which will remain in place) in sections IV.E. (recommendations 15 and 16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus (WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).

The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of September 2, 2016, concerning request for comments on Proposed Data Collection Submitted for Public Comment and RecommendationsAirline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form. The document provided the incorrect docket number (CDC-2016-0088).

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.