Department of Health and Human Services July 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is amending the Agency's regulations by removing certain regulations that include obsolete references. FDA is taking this action to improve the accuracy of the regulations.

The Food and Drug Administration (FDA or Agency) has determined that PARAFON FORTE DSC (chlorzoxazone) tablets, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.

This document amends the notice published in Federal Register, Friday July 8, 2016, volume 81, pages 44639-44640. This notice updates and extends the submission period to August 8, 2016, limits an investigator or co-investigator to one submission and adds prize details. The ``Use of Blockchain in Health IT and Health-related Research'' Ideation Challenge solicits white papers on the topic of Blockchain Technology and the potential use in Health IT to address privacy, security and scalability challenges of managing electronic health record and resources. Up to 15 winners will be awarded a cash prize and up to 8 winners may be invited to present their papers at an upcoming industry-wide workshop co-hosted with the National Institute of Standards and Technology (NIST). The statutory authority for this Challenge is section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this proposed rule, we are proposing to make changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are proposing to remove the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are proposing to implement section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus outpatient departments of a provider.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on August 3, 2016. The subject of the meeting will be ``An Update on the National Diabetes Prevention Program.'' The meeting is open to the public.

This notice of proposed rulemaking (NPRM) proposes changes to the Department of Health and Human Services' (HHS) adoption of the Office of Management and Budget's (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (``Uniform Administrative Requirements'') published on December 19, 2014 (79 FR 75871) and the technical amendments published by HHS on January 20, 2016 (81 FR 3004). HHS codified the OMB language, with noted modifications as explained in the preamble to the December promulgation, in 45 CFR part 75. The HHS-specific modifications to the Uniform Administrative Requirements adopted prior regulatory language that was not in conflict with OMB's language, and provided additional guidance to the regulated community. Unlike all of the other modifications to the Uniform Administrative Requirements, these proposed changes, although based on existing law or HHS policy, were not previously codified in regulation. This NPRM seeks comments on these important proposed regulatory changes.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact*: Ms. Diana Finegold, Office of Communications and Public Liaison, NINR, NIH, Building 31, Suite 5B03, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0209, or Email your request, including your address to: Diana.Finegold@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Palliative Care: Conversations Matter[supreg] Phase Two Evaluation, 0925-NEW, National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: The NINR Palliative Care: Conversations Matter[supreg] initiative, which launched in FY 2014, is now in its second phase. The first phase was focused on providing materials and tools to assist health care providers in having sometimes difficult conversations with children and families about palliative care. The second phase of the campaign, launched in FY 2015, focuses on children, parents, and families. The Palliative Care: Conversations Matter[supreg] Phase Two evaluation will assess the information and materials being disseminated to children, parents, and families. Survey findings will help (1) determine if the campaign is effective, relevant, and useful to the families and caregivers of children living with serious illnesses; (2) to better understand the information needs of families and caregivers to inform future campaign efforts; and (3) examine how effective the campaign materials are in providing families and caregivers with information on palliative care. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 400 hours.

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 ``Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Hospitals.'' This data collection will provide information on the burden and types of healthcare-associated infections, including infections due to antimicrobial-resistant pathogens, and antimicrobial drugs in U.S. short-term acute care hospitals.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will be holding a public teleconference.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms ``commercially available,'' ``essentially a copy of a commercially available drug,'' and ``regularly or in inordinate amounts.''

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device.'' This guidance describes the types of information that should be provided to support a claim of EMC in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference (EMI)). EMC assessment helps to ensure that a device is able to function in its intended environment without introducing excessive electromagnetic disturbances that might interfere with other devices.