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Notification of Request for Emergency Clearance; Evaluation of the Impact of the New Conflicts of Interest Regulations on the National Institutes of Health's Ability To Recruit and Retain Staff

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In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) hereby publishes notification of request for Emergency Clearance for the information collection related to the Evaluation of the Impact of the New Conflicts of Interest Regulations on the National Institutes of Health's Ability to Recruit and Retain Staff.

This information collection is essential to the mission of the NIH [42 U.S.C. 241 and 282(b)(1)]. In December 2003, the House Energy and Commerce Committee raised concerns about potential conflicts of interest at NIH. In response to these concerns, the NIH Director, Dr. Elias Zerhouni, ordered an internal investigation into consulting agreements at NIH and in June 2004 proposed changes to the agency's conflict-of-interest policies. Effective February 3, 2005, the new regulations (5 CFR parts 5501 and 5502, “Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services,” Federal Register, Vol. 70, No. 22 Thursday, February 3, 2005, 5543-5565 ) apply to all NIH employees and place limits on certain financial holdings of employees, their spouses, and minor children and on certain outside activities in which NIH staff may engage. In the brief time since the implementation of the new ethics rules, many key NIH senior scientists have chosen to leave NIH rather than comply with the new regulations.

In the preamble to the rule, HHS stated its intent to evaluate the impact of the new rules within the next year. Gauging both the immediate and longer term impact of these new rules is crucial to NIH's ability to develop and maintain a world-class staff. This project will produce data that will help NIH and HHS leaders determine the impact of the regulations and whether changes should be made, so it is essential that the data are collected while the review of the regulations is still in progress.

NIH cannot reasonably comply with the normal clearance procedures for information collection, because the use of normal procedures will delay the collection and hinder the agency in accomplishing its mission, to the detriment of the public good. NIH has taken all practicable steps to consult with the scientific community and the public in reaching the determination. Several months have elapsed since the publication of the new conflict of interest regulations, and NIH has had several meetings with employees, interviewed senior scientists and has made plans to survey current NIH employees, as well as reviewed more than 1800 comments on the regulations. At this point, NIH intends to survey recent applicants, applicants who have declined to accept employment offers from NIH and potential applicants from scientific organizations from which NIH has traditionally drawn leading scientific personnel. This will allow NIH to determine whether the regulations impact an individual's attitudes about employment at NIH and the likelihood of their joining the agency.

NIH and HHS leaders are still examining and modifying some aspects of the rules. It is essential that these leaders obtain information on the impact of the rules on the career aims and choices of non-NIH scientists and the perception of the scientific community to inform their decision making.

Proposed Collection

Title: Evaluation of the Impact of the New Conflicts of Interest Regulations on the National Institutes of Health's Ability to Recruit and Retain Staff. Type of Information Collection Request: Emergency. Need and Use of Information Collection: To assess the impact of new NIH ethics regulations on the agency's ability to continue to attract and recruit highly qualified scientific personnel. Frequency of Response: One time. Affected Public: Individuals and households. Type of Respondent: Highly Start Printed Page 38696trained and qualified scientists engaged in medicine and life sciences research. The annual reporting burden is as follows: Estimated Number of Respondents: 900; Estimated Number of Responses per Respondent: One; Average Burden Hours Per Response: 10 minutes; and Estimated Total Annual Burden Hours Requested: 150 hours. The annualized cost to respondents is estimated at $4,950. There are no Capital Costs, Operating Costs, or Maintenance Costs to report.

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: 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 contact Michael Rosenthal; Building 31—Claude D Pepper Bldg, Room 3B43, 1 Center Drive, Bethesda, MD 20892;; 301-496-3366.

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Dated: June 24, 2005.

Raynard S. Kington,

Deputy Director, National Institutes of Health.

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[FR Doc. 05-13153 Filed 7-1-05; 8:45 am]