Cover Memo July 9

Cover Memorandum

DEPARTMENT OF HEALTH & HUMAN SERVICES

National Institutes of Health

Bethesda, Maryland 20892

Date: July 9, 2008

To: Office of Management and Budget (OMB)

Through: Ms. Seleda Perryman, Report Clearance Officer, DHHS

Ms. Mikia Currie, NIH Project Clearance Officer, Project Clearance Branch

From: Dr. Jody Sachs, D.P.M.

National Center for Research Resources/NIH

Subject: Inventory and Evaluation of Clinical Research Networks (IECRN) data collection

This is a request for OMB to approve the revision of the IECRN Core Survey (OMB# 0925-0550, expiration 07/31/08. Worksheets, Federal Register Notices, Supporting Statement A, and various attachments accompany this memorandum.

Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data: (1) to create a web-based inventory of clinical research networks (CRNs) and (2) to prepare a detailed description of network practices. The current request is to continue collecting data for the first purpose only, using the Core Survey, which asks for information to confirm eligibility, plus basic characteristics about each CRN (including network name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus). Only those networks that agree will have their information posted. Currently the inventory includes “network profiles” for 270 CRNs. While this number is believed to represent most of the existing networks, some 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. A total of 300 respondents (20 for the Core Survey and 280 for the Annual Update) will be asked to provide network information. The annualized burden for all respondents is 51.7 hours.

The information collected by the IECRN project is essential to further the NIH Roadmap goals, as it provides descriptive information on CRNs that can be utilized to increase the productivity and efficiency of NIH funding to expedite translation of basic research findings into treatments.

If this information collection does not continue, the NIH will be hindered in its goal of re-engineering the clinical research enterprise to make it more productive and efficient. Without accurate and complete information, the NIH will also not be able to reach out to clinical research networks to facilitate their interaction and collaboration, to identify and encourage the adoption of best practices, and to increase openness to greater participation by clinicians and communities.