Department of Health and Human Services July 14, 2008 – Federal Register Recent Federal Regulation Documents

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 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 for Responsible Prospective Contractors, 42 CFR Part 50, Subpart F, and 45 CFR Part 94. Type of Information Collection Request: Revision of OMB No. 0925- 0417, expiration date November 30, 2008. Need and Use of the Information Collection: 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 related recordkeeping requirements regarding contractors in Responsible Prospective Contractors, 45 CFR Part 94. The purpose of these regulations is to promote objectivity in research by requiring institutions to establish standards to 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 or 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: 67,860; Estimated Number of Responses Per Respondent: 1.60; Averaged Burden Hours per Response: 3.40.; and Estimated Total Annual Burden Hours Requested: 220,280. The annualized cost to the public is estimated at $8,120,000. Operating Costs and/or maintenance costs are $4,633.00.