# Proposed Collection; Proposed Revision of Approved Collection; Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought, 42 CFR Part 50, Subpart F and for Responsible Prospective Contractors, 45 CFR Part 94
*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 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.
| Type of respondents based on applicable section of regulation | Number of | Frequency of | Average | Annual hour |
| --- | --- | --- | --- | --- |
| Reporting: | | | | |
| Initial Reports under 42 CFR § 50.604(g)(2) or 45 CFR 94.4(g)(2) from Institutions | 300 | 1 | 80 | 24000 |
| Subsequent Reports under 42 CFR § 50.604(g)(2) or 45 CFR 94.4(g)(2) from Institutions | 40 | 1 | 2 | 80 |
| Subsequent Reports under 42 CFR § 50.606(a) or 45 CFR 94.6 from Institutions | 20 | 1 | 10 | 200 |
| Recordkeeping: Under 42 CFR § 50.604(e) or 45 CFR 94.4(e)—Institutional files | 25000 | 1 | 4 | 100000 |
| Disclosure: | | | | |
| Under 42 CFR § 50.604(a) or 45 CFR 94.4(a)—Institutions | 2800 | 1 | 20 | 56000 |
| Under 42 CFR § 50.604(c) or 45 CFR 94.4(c)—Investigators | 40000 | 1 | 1 | 40000 |
| Totals | 67860 | | | 220280 |
**Requests 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 functions of the agency, including whether the information shall have practical utility; (2) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed information collection; (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 respondents, including through 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: Ms. Mikia Currie, Assistant Project Clearance Officer, 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 301-435-0941 or e-mail your request, including your address, to: *[email protected]* .
*Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Dated: May 19, 2008.
Joe Ellis,
Director, Office of Policy of Extramural Research Administration, OER, National Institutes of Health.