Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents

This final rule will set forth the hospice wage index for fiscal year (FY) 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This final rule will change the hospice aggregate cap calculation methodology. This final rule will also revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this final rule will begin implementation of a hospice quality reporting program.

This document contains amendments to the interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule on the ``gluten-free'' labeling of foods, published in the Federal Register of January 23, 2007 (72 FR 2795). In that document, FDA proposed to define the term ``gluten- free,'' for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term ``gluten-free'' in the final rule. A report by FDA discussing a health hazard assessment we conducted, which included a safety assessment for gluten exposure in individuals with celiac disease, has been peer reviewed by an external group of scientific experts, and we revised the assessment, as appropriate, based upon expert comments. FDA is reopening the comment period for the proposed rule on the ``gluten- free'' labeling of foods to, in part, announce the availability of and solicit comments on the report entitled ``Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten'' (``Gluten Report''), which discusses the Agency's gluten safety assessment. The Agency also seeks comments on whether and, if so, how, the safety assessment should affect FDA's proposed definition of ``gluten-free'' in the final rule, and on a number of related issues. Finally, FDA seeks comments on the Agency's tentative conclusions that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure; and that the final rule should adopt the proposed rule's approach to defining the term ``gluten-free,'' because that approach takes into account the availability of reliable analytical methods and also considers other practical factors related to the needs of individuals with celiac disease and their food consumption.

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 reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.

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 associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the U.S. Government.

This proposed rule reflects the Centers for Medicare and Medicaid Services' commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled ``Improving Regulation and Regulatory Review,'' as this rule would: implement a new reconsideration process for administrative determinations to disallow claims for Federal financial participation (FFP) under title XIX of the Act (Medicaid); lengthen the time States have to credit the Federal Government for identified but uncollected Medicaid provider overpayments and provide that interest will be due on amounts not credited within that time period; make conforming changes to the Medicaid and Children's Health Insurance Program (CHIP) disallowance process to allow States the option to retain disputed Federal funds through the new administrative reconsideration process; revise installment repayment standards and schedules for States that owe significant amounts; provide that interest charges may accrue during the new administrative reconsideration process if a State chooses to retain the funds during that period. This proposed rule would also make a technical correction to reporting requirements for disproportionate share hospital payments, revise internal delegations of authority to reflect current CMS structure, remove obsolete language, and correct other technical errors.

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: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Health Resources and Services Administration (HRSA) announces the eligibility criteria, including their Health Professional Shortage Area (HPSA) scores, for entities that are seeking to recruit National Health Service Corps (NHSC) scholarship recipients (Corps Personnel, Corps members) during the period July 1, 2011, through June 30, 2012. A searchable database that specifies all currently approved NHSC service sites is posted on the NHSC Web site at https:// datawarehouse.hrsa.gov/HGDWReports/ OneClickRptFilter.aspx?rptName=NHSCAppSiteList&rptFormat=HTML 3.2. This database can be searched by State and can be utilized to determine which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program based on the threshold HPSA score set forth below. Please note that entities on this list may or may not have current job opportunities for NHSC scholars. Further, not all vacancies associated with sites on the list described below will be for Corps members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.'' The establishment of this public docket does not signify FDA endorsement or concurrence with any of the conclusions or recommendations contained within the report. FDA may, in the future, take additional measures to solicit public input in the report and specific recommendations contained therein. FDA will not adopt any of the recommendations contained in the report before the close of this comment period.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees for certain periodic reports and for certain establishments subject to registration. The FY 2012 fee rates are provided in this document. These fees apply from October 1, 2011, through September 30, 2012. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. In order to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will be required to pay the higher standard fee. This document provides information on how the fees for FY 2012 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. The Agency is seeking public comment on what burdens these fees impose on small business, and whether and how the Agency should alleviate such burdens. In particular, the Agency is seeking public comments on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors the Agency should consider for each. In addition, the Agency is seeking public comment on how small business should be defined or recognized. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and share views that will inform future Agency actions with respect to these matters.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2012 fee rates for certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections that are mandated in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. Invoices for these fees for FY 2012 will be issued using the fee schedule established in this document. FDA is accepting comments to this document and intends to consider such comments in implementing these user fees in FY 2013.