02-16429. Submission for OMB Review; Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors-42 CFR Part 50, Subpart F

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), 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 October 9, 2001, pages 51440-51441 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: Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors—42 CFR part 50, subpart F, Type of Information Collection Request: Revision of OMB No. 0925-0417, expiration date 4/30/02. Need and Use of Information Collections: This is a request for OMB approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR part 50 subpart F and Responsible Prospective Contractors: 45 CFR part 94. The purpose of the regulations is to promote objectivity in research by requiring institutions to establish standards which ensure that there is no reasonable expection that the design, conduct, or reporting of research will be biased by a conflicting financial interest of an investigator. Frequency of Response: On occasion. Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions; State, Local, or Tribal Government. Type of Respondent: Any public or private entity or organization. The annual reporting burden is as follows; Estimated Number of Respondents: 42,800; Estimated Number of Responses per Respondent: 1.60; Average Burden Hours per Response: 3.40; and Estimated Total Annual Burden Hours Requested: 232, 080. The annualized costs to respondents is estimated at: $8,120,000. Operating costs and/or Maintenance Costs are $4,633.

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, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Charles MacKay, Ph.D., Chief, Project Clearance Branch, Office of Extramural Research (OER), Office of Policy for Extramural Research Administration (OPERA), 6705 Rockledge Drive, Room 3509, Bethesda, MD 20892-7974 or call non-toll-free number [phone] or E-mail your request including your address to: [e-mail].

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: June 20, 2002.

Regina H. White,

Director, Office of Policy for Extramural Research Administration, OER, NIH.