Department of Health and Human Services September 15, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) are announcing the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. FDA and FSIS are particularly interested in research that will help both organizations understand current and emerging practices by industry in sodium reduction in foods; current consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices; motivation and barriers in reducing sodium in their food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction of excess sodium intake. Excess sodium intake is linked to increased risk of heart disease and stroke. FDA and FSIS recognize ongoing efforts by a number of members of the restaurant and packaged food industries to reduce sodium and appreciate the complexities of reducing sodium in foods. Continued input and support from industry and other stakeholders are important to support further progress on this significant public health issue.

Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

HHS gives notice of a decision to designate a class of employees from the General Electric Co. in Evendale, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 31, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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: ``Medical Expenditure Panel SurveyInsurance Component 2012- 2013.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 30th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (207) entitled ``Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,'' (VICH GL48). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (205) entitled ``Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of Residues (MRK),'' (VICH GL46). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations for internationally harmonized test procedures to study the quantity and nature of residues of veterinary drugs in food- producing animals.