Department of Health and Human Services April 13, 2010 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act, OMH proposes to establish a new system of records entitled, ``Minority Health Information Service.'' Under provisions of 42 U.S.C. sec. 300u- 6, the Office of Minority Health (OMH) is charged with maintaining a national minority health resource center to (1) Facilitate exchange of and access to information related to health information, promotion, services and education; (2) assist in analysis of issues and problems with regard to such matters; and (3) provide technical assistance with regard to the exchange of such information. The primary purpose of this system is to collect and facilitate distribution of minority health information to public and professional audiences. In support of this purpose, this system maintains individually identifiable information concerning individuals voluntarily participating in OMH health campaigns and technical assistance programs, and concerning information requested by individually identifiable customers that is maintained to facilitate order tracking and customer service.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Steering Committee and Expert Working Group Meetings in Tallinn, Estonia'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Tallinn, Estonia. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Tallinn, Estonia, June 5 through 10, 2010, at which discussion of the topics underway and the future of ICH will continue.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of July 9, 2009, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. Elsewhere in this issue of the Federal Register, FDA is amending its July 9, 2009, regulation to correct the date by which producers must register their farm with FDA,

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models.'' The workshop will include a smaller, optional session entitled ``Microstructure Modeling Session.'' FDA is cosponsoring the workshop with the National Heart Lung and Blood Institute of the National Institutes of Health and the National Science Foundation. The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices.