Department of Health and Human Services August 2014 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 March 19, 2014, pages 15351 and 15351 [FR DOC : 2014-06064], and allowed 60 days for public comment. There was 1 public comment received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@ omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA), the American Academy of Ophthalmology (AAO), the American Academy of Optometry (AAOpt), the American Optometric Association (AOA), and the Contact Lens Association of Ophthalmologists, Inc. (CLAO), are cosponsoring a public workshop entitled ``Revamping Microbiological Test Methods for Contact Lenses, Products, and Accessories.'' The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies. Participants will explore the pros and cons of the various proposals for disinfection efficacy testing and aid in developing general recommendations. The workshop will assist in informing the regulatory science for evaluating contact lenses and disinfection efficacy of associated care products as well as improving test methods to mitigate potential infections.

The Food and Drug Administration (FDA) is announcing the availability of the action plan issued as required by section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the reopening of a public docket for comments pertaining to the action plan.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Protecting Access to Medicare Act of 2014, and other legislation. These changes are applicable to discharges occurring on or after October 1, 2014, unless otherwise specified in this final rule. We also are updating the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of-increase limits are effective for cost reporting periods beginning on or after October 1, 2014. We also are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implementing certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition, we discuss our proposals on the interruption of stay policy for LTCHs and on retiring the ``5 percent'' payment adjustment for co-located LTCHs. While many of the statutory mandates of the Pathway for SGR Reform Act apply to discharges occurring on or after October 1, 2014, others will not begin to apply until 2016 and beyond. In addition, we are making a number of changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments. We are establishing new requirements or revising requirements for quality reporting by specific providers (acute care hospitals, PPS- exempt cancer hospitals, and LTCHs) that are participating in Medicare. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. In addition, we are making technical corrections to the regulations governing provider administrative appeals and judicial review; updating the reasonable compensation equivalent (RCE) limits, and revising the methodology for determining such limits, for services furnished by physicians to certain teaching hospitals and hospitals excluded from the IPPS; making regulatory revisions to broaden the specified uses of Medicare Advantage (MA) risk adjustment data and to specify the conditions for release of such risk adjustment data to entities outside of CMS; and making changes to the enforcement procedures for organ transplant centers. We are aligning the reporting and submission timelines for clinical quality measures for the Medicare EHR Incentive Program for eligible hospitals and critical access hospitals (CAHs) with the reporting and submission timelines for the Hospital IQR Program. In addition, we provide guidance and clarification of certain policies for eligible hospitals and CAHs such as our policy for reporting zero denominators on clinical quality measures and our policy for case threshold exemptions. In this document, we are finalizing two interim final rules with comment period relating to criteria for disproportionate share hospital uncompensated care payments and extensions of temporary changes to the payment adjustment for low-volume hospitals and of the Medicare- Dependent, Small Rural Hospital (MDH) Program.

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 Center for Scientific Review (CSR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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, contact Dr. Mary Ann Guadagno, Center for Scientific Review, NIH, Room 3182, 6701 Rockledge Drive, Bethesda, MD 20892, or call non-toll-free number 301-435-1251 or email your request, including your address to: guadagma@csr.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of publication of the notice. Proposed Collection: Generic Clearance for Satisfaction Surveys of Customers (CSR), Extension0925-0474expiration date 10/31/2014, Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: We will continue to collect information in surveys for use by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys, which will be both quantitative and qualitative, are designed to assess the quality of services we provide to our major external customers. Customers include the research scientists who submit applications for grant funding to NIH. Those grant applications are reviewed and ranked by the grant scientific peer review study groups' members and chairs. These surveys will almost certainly lead to quality improvement activities that will enhance and/ or streamline CSR's operations. Our voluntary partners include current grant scientific peer review study groups' members and chairs. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4,263.

The Food and Drug Administration (FDA) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens.

Notice is hereby given of the National Institutes of Health (NIH) ``Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain,'' which is open to the public.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 20, 2014. The challenge will be open until October 10, 2014. Million Hearts[supreg] is a national initiative to prevent 1 million heart attacks and strokes by 2017. Achieving this goal means that 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to care, as well as community approaches, such as strengthening tobacco control, and lowering sodium consumption. For more information about the initiative, visit www.millionhearts.hhs.gov. To support improved blood pressure control, HHS/CDC is announcing the 2014 Million Hearts[supreg] Hypertension Control Challenge. The challenge will bring prestige to organizations that invest in hypertension control, improve understanding of successful implementation strategies at the health system level, and motivate practices and health systems to strengthen their hypertension control efforts. The challenge will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive a cash prize and local and national recognition.

The Indian Health Service published a document in the Federal Register on July 29, 2014, for the FY 2014 Office of Tribal Self- Governance Program, Negotiation Cooperative Agreement Announcement. The notice contained an incorrect date.

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institute of Mental Health (NIMH) will host a meeting to enable public discussion of the Institute's proposal to merge the Division of Adult Translational Research with the Division of Translational Research. The proposal seeks to capitalize on emerging scientific opportunities, while reducing barriers to scientific and interdisciplinary collaboration. This public meeting will take place on August 28, 2014. Information is available on the Institute's Web site, https://www.nimh.nih.gov/ index.shtml, where links to an agenda and any additional information for the meeting will be posted when available.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development grant program. The goal of FDA's Orphan Products Development (OPD) grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.