Department of Health and Human Services February 6, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T- Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance document provides blood collection establishments with recommendations regarding the use of serological tests to reduce the risk of HTLV-I/II transmission by blood and blood components. The guidance announced in this notice finalizes the draft guidance entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)'' dated September 2018. The guidance also consolidates FDA's other previously issued recommendations on HTLV-I/II into one document. Therefore, the guidance also supersedes the recommendations specific to HTLV-1 contained in the memorandum to blood establishments entitled ``Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T- Lymphotropic Virus Type I (HTLV-I)'' dated July 1996. In addition, the guidance supersedes the memorandum to blood establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated November 1988; the memorandum to blood establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated July 1989; and the document entitled ``Guidance for Industry: Donor Screening for Antibodies to HTLV-II'' dated August 1997.

HRSA is soliciting comments and recommendations regarding HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and is seeking nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA TAC. The HRSA TAC will engage in regular and meaningful collaboration and consultation with tribal officials on policies that have tribal implications and a substantial direct effect on Indian tribes. The HRSA TAC will be the vehicle for acquiring a broad range of tribal views, determining the impact of HRSA programs on the American Indian/Alaska Native (AI/AN) health systems and population, developing innovative approaches to deliver health care and assisting with effective tribal consultations. HRSA is also seeking nominations of qualified candidates to fill up to 12 positions on the HRSA TAC; one authorized tribal representative (and one designated alternate) from each of the 12 Indian Health Service geographic areas.

NIOSH announces the availability of the final National Occupational Research Agenda for Healthy Work Design and Well-Being.

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with the notice requirements of NAPA, ANA herein describes proposed general statements of policy that relate to the Native American Language Preservation and MaintenanceEsther Martinez Immersion (EMI) funding opportunity announcement (FOA) in fiscal year (FY) 2020.