Submission for OMB Review; 30-Day Comment Request; National Institute of Mental Health Recruitment and Milestone Reporting System

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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 2, 2013, page 46994 and allowed 60-days for public comment. One public comment was received regarding human subjects research recruitment and retention and the perception of coercion. The recruitment and enrollment procedures proposed by a NIMH-funded clinical trial are reviewed and approved by an IRB of record, which has agreed to review human subject research projects in accordance with 45 CFR Part 46 and its Federal-wide Assurance. The IRB of record ensures that the possibility of coercion or undue influence is minimized, that an investigator seeks consent only under circumstances that provide the prospective subject/representative sufficient opportunity to consider whether or not to participate. To address these concerns, we plan to add a statement about human subject protections to the policy and add a link to the human subjects training on the policy Web page. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), 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. 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment 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.