Department of Health and Human Services May 21, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.'' This guidance provides recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or pituitary gland. This guidance incorporates advice FDA received at a December 2014 advisory committee meeting on the appropriate indicated population for testosterone therapy and a December 2016 advisory committee meeting on hypogonadotropic hypogonadism. This guidance finalizes the draft guidance of the same name issued on January 3, 2018.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the investigation of consumer perceptions of expressed modified risk claims.

The Food and Drug Administration (FDA or we) is denying a food additive petition (FAP 5A4811), submitted by the Grocery Manufacturers Association (GMA), requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. We are denying the petition because we have determined that the petitioner did not provide sufficient information for us to conclude that the requested uses of PHOs are safe. To allow the food industry sufficient time to identify suitable replacement substances for the petitioned uses of PHOs, elsewhere in this issue of the Federal Register we have extended the compliance date for certain uses of PHOs, including the conditions of use covered by the FAP.

This notice announces that the listing of entities that will receive priority for assignments of National Health Service Corps (NHSC) Scholarship recipients (NHSC scholars) was posted on the Health Workforce Connector website (formerly known as the NHSC Jobs Center) at https://connector.hrsa.gov/. The Health Workforce Connector includes sites approved to receive an assignment of NHSC scholars who are available for service during the period of October 1, 2018, through September 30, 2019, as well as the site's Health Professional Shortage Area (HPSA) scores. Please note that entities on this list may or may not have current job vacancies.