Department of Health and Human Services October 10, 2017 – Federal Register Recent Federal Regulation Documents

The Secretary of the Department of Health and Human Services hereby issues this final notice to re-designate the Purchased/Referred Care Delivery Area (PRCDA) for the Tolowa Dee-ni' Nation (Tribe) (previously known as the Smith River Rancheria of Smith River, California), to provide Purchased/Referred Care (PRC) services to their Tribal members residing in Curry County, Oregon, which is in the Portland Area Indian Health Service (IHS). The Tolowa Dee-ni's Tribal Headquarters is located 3 miles south of the California-Oregon border in Northern California. The entire State of California, excluding the counties of Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura, was designated by the IHS as a PRCDA, formerly known as a Contract Health Service Delivery Area, in accordance with statute. The current PRCDA for Tolowa Dee-ni' Tribal members is the statutorily specified California PRCDA. The expanded PRCDA for the Tolowa Dee-ni' Tribe includes the statutorily specified California PRCDA and Curry County in the State of Oregon.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. In order to work continuously to ensure that our programs are effective and meet our customers' needs, the National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC) seeks to obtain Office of Management and Budget approval of a generic information collection request to collect qualitative feedback on our service delivery.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed study titled ``Understanding Decisions and Barriers about PrEP Use and Uptake among Men Who Have Sex with Men.'' This study will provide insight on individual and community level PrEP-related decision-making, and identify barriers and facilitators to successful PrEP initiation and PrEP acceptability.

The Department of Health and Human Services, National Institutes of Health published a document in the Federal Register on October 2, 2017, contemplating the modification of grant of an Exclusive Patent License to EncepHeal Therapeutics, Inc., located in Winston-Salem, North Carolina, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice. The document contained an incorrect date of signature.

The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.