Department of Health and Human Services March 5, 2019 – Federal Register Recent Federal Regulation Documents

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a revision to an existing Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the revision of the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the guidance on informed consent for in vitro diagnostic (IVD) device studies using leftover human specimens that are not individually identifiable.

This notice is to advise the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/Referred Care (PRC) Delivery Area (DA) for the Havasupai Tribe in Arizona. The Havasupai Tribe's PRCDA is currently Coconino County in the State of Arizona. The IHS proposes to expand the Tribe's PRCDA to include Mojave County, which is adjacent to the Tribe's existing PRCDA in the State of Arizona.