Department of Health and Human Services March 2017 – Federal Register Recent Federal Regulation Documents

This notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area for the Tolowa Dee-ni' Nation (Tribe) previously known as the Smith River Rancheria of Smith River, California. The Tolowa Dee- ni's Tribal Headquarters is located three 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, are designated a Purchased/Referred Care (PRC) Service Delivery Area, formerly referred to as a Contract Health Service Delivery Area, by statute. The current Service Delivery Area for the Tolowa Dee-ni' Nation Tribal members is the statutorily established California PRC Service Delivery Area. The expanded PRC Service Delivery Area for the Tolowa Dee-ni' Nation includes the statutorily established California PRC Service Delivery Area and Curry County in the State of Oregon.

The Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number designations in section headings, and to reflect a change in an office's name. This action is ministerial or editorial in nature.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 29, 2016, page 96020 (Vol. 81, No. 250) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in:

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Agriculture Select Agent Services (AgSAS) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance and information related to the Federal Select Agent Program for interested individuals.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 information collection project titled ``Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease.'' This project consists of telephone interviews with participants in Puerto Rico and the domestic U.S.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announces the request for information about facilities that stockpile N95 respirators and high-level protective surgical gowns.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for the Collection of Data Through ACTION III Field-Based Investigations to Improve Health Care Delivery.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 20, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation.