Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

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 the evaluation of the progress of CDC partners that receive awards distributed via contracts, grants and cooperative agreements, from the Procurements and Grants Office (PGO). PGO is responsible for the stewardship of these funds while providing excellent, professional services to our partners and stakeholders. Data will be collected for the purpose of evaluating the progress of programmatic activities.

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 entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement.'' CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.

This final rule will update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this rule implements the 3rd year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provides a clarification regarding the use of the ``initial encounter'' seventh character applicable to certain ICD-10-CM code categories. This final rule will also finalize reductions to the national, standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 2018 of 0.97 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014. In addition, this rule implements a HH value-based purchasing (HHVBP) model, beginning January 1, 2016, in which all Medicare-certified HHAs in selected states will be required to participate. Finally, this rule finalizes minor changes to the home health quality reporting program and minor technical regulations text changes.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Administration for Children and Families reopens the comment period for the notice of proposed rulemaking entitled, ``Comprehensive Child Welfare Information System.'' We take this action to respond to requests from the public for more time to submit comments. The notice of proposed rulemaking and our request for comments appeared in the Federal Register on August 11, 2015. We initially set October 13, 2015 as the deadline for the comment period. The Web site for submitting public comments, https:// www.regulations.gov, experienced technical difficulties and was unavailable for periods of time during the several days prior to this deadline and many commenters reported difficulty submitting their comments using this mechanism. To allow the public more time, we are reopening the comment period for an additional 7 days.

In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Department of Health and Human Services (HHS) is updating an existing, department-wide system of records, System No. 09-90-0024, titled ``Unified Financial Management System'' (UFMS), which covers accounts payable records and accounts receivable records retrieved by personal identifier; and is transferring one routine use (pertaining to administrative wage garnishment) to a related system of records, System No. 09-40-0012, titled ``Debt Management and Collection System.'' System No. 09-90-0024, ``Unified Financial Management System,'' was established prior to 1979 (see 44 FR 58149). The System of Records Notice (SORN) was last revised and republished in full in 2005 (see 70 FR 38145). This Notice proposes to change the name to ``HHS Financial Management System Records;'' update records locations and System Manager contact information; narrow the scope of the SORN by excluding certain descriptions and routine uses pertaining to collection of overdue and delinquent federal debts, which are currently covered in, or are now proposed to be covered in, the SORN for System No. 09-40- 0012 ``Debt Management and Collection System;'' add several new routine uses, combine and revise certain existing routine uses, and delete unnecessary routine uses; and update the safeguards, record retention procedures, and record source descriptions. The changes are more fully explained in the Supplementary Information section of this Notice.

The Food and Drug Administration (FDA or Agency) is announcing a regional public webinar entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).'' The goal of this webinar is to provide information and receive comments on the ICH, as well as the upcoming ICH meetings in Jacksonville, FL, in December 2015. The topics to be discussed are the topics for discussion at the forthcoming ICH Management Steering Meeting. The purpose of the webinar is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Jacksonville, FL, scheduled for December 5 to 10, 2015, at which the discussion of the topics underway and ICH reforms will continue.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs and therapeutic biologic products for the treatment of HIV-1 infection.

This document extends the comment period for the notice to propose Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah), which was published in the Federal Register on October 5, 2015. The comment period for the notice, which would have ended on October 23, 2015, is extended by 30 days.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

In this request for information (RFI), we seek public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. Specifically, we are interested in obtaining information on core access to care measures and metrics that could be used to measure access to care for beneficiaries in the Medicaid program (including in fee-for- service and managed care delivery systems) and used to develop local, state and national thresholds and goals to inform and improve access in the program. We are also interested in feedback on approaches to using the metrics, which could include setting access goals and thresholds and formal processes for beneficiaries to raise access concerns.