E8-12383. Submission for OMB Review; Comment Request; Inventory and Evaluation of Clinical Research Networks

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources (NCRR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 24, 2008, Vol. 73, No. 57, page 15530, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

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).

Table A12.1.—Estimate of Annual Hour Burden and Annualized Cost to Respondents

Type of respondent	Number of responses	Frequency of response	Time per response (minutes/hours)	Annual burden hour	Hourly wage rate	Respondent cost
Core Survey
Principal Investigator	20	1	15/60	5	70.00	350.00
Annual Update
PI/network contact	280	1	10/60	46.6667	70.00	3,266.67
Total				51.7		$3,616.67

The annualized cost to respondents is estimated at: $3,617. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, or [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Jody Sachs, National Center for Research Resources, NIH, Room 917, 6701 Rockledge Drive, Bethesda, MD 20892-4874, or call 301-435-0802.

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

Dated: May 29, 2008.

Jody Sachs,

Project Officer, NCRR, National Institutes of Health.