E8-23171. Submission for OMB Approval; Comment Request; Extension of Approved Collection; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought, 42 CFR Part 50, Subpart F and for ...

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 14, 2008 (Vol. 73, No. 135, p. 40354-40355) and allowed 60-days for public comment. There were no public comments received during this time. 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 for Responsible Prospective Contractors, 42 CFR Part 50, Subpart F, and 45 CFR Part 94.

Type of Information Collection Request: Extension 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.

TABLE—Estimates of Hour Burden

Type of respondents based on applicable section of regulation	Number of respondents	Frequency of response	Average burden hours per response	Annual hour burden
Reporting
Initial Reports under 42 CFR § 50.604 (g)(2) or 45 CFR 94.4(g) (2) from Institutions	i 300	1	80 Hours	24000
Subsequent Reports under 42 CFR § 50.604 (g)(2) or 45 CFR 94.4(g)(2) from Institutions	ii 40	1	2 Hours	80
Subsequent Reports under 42 CFR § 50.606 (a) or 45 CFR 94.6 from Institutions	iii 20	1	10 Hours	200
Record Keeping
Under 42 CFR § 50.604 (e) or 45 CFR 94.4 (e)—Institutional files	iv 25000	1	4 Hours	100000
Disclosure
Under 42 CFR § 50.604(a) or 45 CFR 94.4 (a)—Institutions	v 2800	1	20 Hours	56000
Under 42 CFR § 50.604(c) or 45 CFR 94.4 (c)—Investigators	vi 40000	1	1 Hour	40000
Totals	68160			220280
i Although not more than 300 reports of Conflict of Interest are expected, the responding institutions must review all financial disclosures associated with PHS funded awards to determine whether any conflicts of interest exist. Thus, the total burden of 24,000 hours is based upon estimates that it will take on the average 4/5 of an hour to review each of 30,000 financial disclosures associated with PHS funding awards. (30,000 x 48 (minutes per file) =1,440,000 ÷ 60 minutes = 24,000 (total hours).
ii The burden for subsequent reports of conflicts (made during the 12 month period following the initial report) is significantly less, because we do not expect may additional reportable conflicts and there will be only a limited number of disclosures to review.
iii This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the failure of an investigator to comply with the institution's conflict of interest policy has biased the design, conduct or reporting of the research. “Objectivity in Research, Final Rule” 60 FR 132 (July 11, 1995) pps. 35810-35819. This burden estimate and others was increased in 2002 “due to increased numbers of institutions and investigators.”
iv Assumes 2500 Institutions, 10 responses per year per institution.
v Assumes 2800 recipient Institutions and 20 hours per institution informing each investigator of institutional policy.
vi The financial disclosure burden estimate is based upon an investigator figure of 40,000 with an average response time of 1 hour. The estimated number of investigators has not changed since the 2002 Information Collection Request associated with the Final Rule. These estimates are for the burden imposed by disclosure, reporting and recordkeeping requirements. Not all activities of institutions related to conflict of interest result from regulations.

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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 Attention: NIH Desk Officer, Office of Management and Budget, at [e-mail] or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans 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: [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: September 25, 2008.

Joe Ellis,

Director, Office of Policy of Extramural Research Administration, National Institutes of Health.