Department of Health and Human Services August 3, 2011 – Federal Register Recent Federal Regulation Documents

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.