01-25169. Proposed Collection; 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:

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 date collection projects, the Office of the Director (OD), 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: 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 03/31/2002. 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 expectation 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 of other for-profit; Not-for-profit institutions; State, Local or Tribal Government. Type of Respondents: 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: 232,000. 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.

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: Charles MacKay, Chief, Project Clearance Branch, Office of Extramural Research (OER), Office of Policy for Extramural Research Administration (OPERA), 6705 Rockledge Drive, Room 1198, 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 on or before December 10, 2001.

Dated: September 26, 2001.

Carol Tippery,

Acting Director, OPERA, NIH.