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

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.

This notice requests members of the public to nominate experts to provide individual input into the CHIPRA Pediatric Quality Measures Program. Section 401(a) of the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3) amended the Social Security Act (the Act) by adding Section 1139A, which directs the Secretary of the Department of Health and Human Services (HHS) to establish a Pediatric Quality Measures Program. The purpose of the Pediatric Quality Measures Program is to (a) Improve and strengthen the initial core child health care quality measures established pursuant to Section 1139A(a) of the Act; (b) expand on existing quality measures used by public and private health care purchasers and advance the development of such new and emerging quality measures; and (c) increase the portfolio of evidence-based, consensus pediatric quality measures available to public and private purchasers of children's health care services, providers, and consumers. A meeting of the experts will be held on September 18, 2011, in Bethesda, Maryland. We are seeking experts who can provide individual comment on the criteria by which new or enhanced children's health care quality measures will be evaluated. Expert panels will be convened in subsequent years to evaluate new or enhanced children's health care quality measures using these criteria. These evaluations will take place annually before recommended changes to the core set of children's health care quality measures are published in the Federal Register on or before January 1, 2013; January 1, 2014; and December 31, 2014. The initial core set of children's health care quality measures was published December 29, 2009, in Volume 74, No. 248 of the Federal Register. Section 1139A(b) of the Act identifies several minimum criteria that the core set of children's health care quality measures must meet and requires consultation with stakeholders in identifying gaps in existing pediatric quality measures and establishing priorities for development and advancement of such measures. AHRQ will convene a group of experts representing a broad range of stakeholder groups. These experts will be asked to provide individual comments on the additional aspects of validity, feasibility, importance, understandability, or other criteria that should be considered when reviewing quality measures. They will also be asked to provide individual comments on the documentation required to provide evidence that each criterion has been met. We seek nominations for a panel of 15 experts that will include representatives from among the following groups: State Medicaid Programs and Children's Health Insurance Programs (CHIP); pediatricians, children's hospitals, and other primary and specialized pediatric health care professionals (including members of the allied health professions) who specialize in the care and treatment of children, particularly children with special physical, mental, and developmental health care needs; dental professionals, including pediatric dental professionals; health care providers that furnish primary health care to children and families who live in urban and rural medically underserved communities or who are members of distinct population sub-groups at heightened risk for poor health outcomes; national organizations representing children, including children with disabilities and children with chronic conditions; national organizations representing consumers and purchasers of children's health care; national organizations and individuals with expertise in pediatric health quality measurement; and voluntary consensus standards setting organizations and other organizations involved in the advancement of evidence-based measures of health care. Individuals, who are affiliated with the CHIPRA PQMP Centers of Excellence as subcontractors, stakeholders, or key personnel (``affiliated individuals''), are not eligible to apply. However, other individuals from entities represented by the affiliated individuals are eligible to apply. We are seeking individuals who are distinguished in their knowledge of health care disparities (e.g., racial and ethnic disparities), child health quality measurement methods, and the application of health information technology to quality measurement. Individuals are particularly sought with experience and success in activities specified in the summary above.

The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of respirators approved under 42 CFR Part 84 by the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and Health Administration (MSHA). NIOSH has reviewed the comments it received to the proposed rule and determined that additional analysis is needed to assess the economic impact of its proposed rule. NIOSH plans to seek further information and to consider possible alternative approaches.

The Food and Drug Administration (FDA) is extending the comment period for the notice of public meeting, that appeared in the Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA requested comments to gather stakeholder input on the development of a generic drug user fee program. The Agency is taking this action to allow interested persons additional time to submit comments.

This document corrects technical errors that appeared in the notice published in the May 20, 2011 Federal Register entitled ``Medicare Program; Pioneer Accountable Care Organization Model: Request for Applications.''

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the National Association of County and City Health Officials (NACCHO). The goal of the cooperative agreement for CFSAN is to have NACCHO conduct work that will strengthen the role of local health departments and help FDA/CFSAN promote effective city and county regulatory programs responsible for retail food protection in the United States.

This rule proposes to implement new statutory requirements regarding the release and use of standardized extracts of Medicare claims data to measure the performance of providers and suppliers in ways that protect patient privacy. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers of services and suppliers.

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 requirements related to the recall of infant formula.

The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of methyl esters of conjugated linoleic acid (CLA) as a source of fatty acids in lactating dairy cow diets and for use of silicon dioxide as a carrier for the methyl esters of CLA.

The Food and Drug Administration (FDA) has determined that ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met.

This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider- preventable conditions for which Medicaid payment will be prohibited.

This proposed notice sets forth proposed revisions to work relative value units (RVUs) and corresponding changes to the practice expense and malpractice RVUs affecting payment for physicians' services. The statute requires that we review RVUs no less often than every 5 years. This is our Fourth Five-Year Review of Work RVUs since we implemented the physician fee schedule (PFS) on January 1, 1992. These revisions to work RVUs are proposed to be effective for services furnished beginning January 1, 2012. These revisions reflect changes in medical practice and coding that affect the relative amount of physician work required to perform each service as required by the statute. The Fourth Five-Year Review of Work includes services that were submitted through public comment and by the Medicare contractor medical directors (CMDs), as well as a number of potentially misvalued codes identified by CMS (that is, Harvard valued codes and codes with Site-of-Service anomalies).

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (159) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI'' (VICH GL36(R)). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of February 11, 2005, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised VICH guidance was revised to include Appendix DSupplement to Section 2 Regarding the Determination of the Fraction of Oral Dose Available to Microorganisms. This draft VICH guidance document is intended to provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Restaurant Menu and Vending Machine Labeling: Registration for Small Chains Under Section 4205 of the Patient Protection and Affordable Care Act of 2010'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.