Department of Health and Human Services March 24, 2008 – Federal Register Recent Federal Regulation Documents

This notice announces an administrative hearing to be held on May 7, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Texas SPA 07-011. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by April 8, 2008.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Research Resource (NCRR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: Revision of OMB 0925-0550. Expiration: 07/31/08. Need and Use of Information Collection: Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data for two purposes: (1) To create a web-based inventory of clinical research networks that can be accessed by the clinical research community and the general public and (2) to prepare a detailed description of existing network practices from a sample of identified networks. The current request is to continue collecting data for the first purpose only. The instrument known as the Core Survey will be used to collect information to confirm that the respondent is truly a clinical research network, plus basic characteristics about each identified clinical research network to be included in the web-based inventory. The information for the inventory database includes the network's name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus. Permission to post the network's data in the web-based public inventory will be requested, and only those networks that agree will have their information posted. Currently the inventory includes ``network profiles'' for approximately 270 clinical research networks. While this number is believed to represent most of the existing networks, some networks have not yet been identified, are unaware of the existence of the inventory, or are newly formed since the original data collection occurred. In addition, each network in the inventory is requested annually to update the information posted in its ``network profile'' to ensure that the inventory is complete and accurate. Frequency of Response: Once (Core Survey), Annually (Network Updates). Affected Public: Individuals. Type of Respondents: Health Professionals (Physicians and others involved in research networks).