Department of Health and Human Services March 6, 2013 – Federal Register Recent Federal Regulation Documents

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 January 2, 2013 (Volume 78, Page 105) and allowed 60-days for public comment. Two public comments were received and responded to. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. 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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Cheng Yi Liang, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Mr. Liang was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for the development or approval, of a drug product. Mr. Liang was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Liang failed to respond. Mr. Liang's failure to respond constitutes a waiver of his right to a hearing concerning this action.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 4040-0004, which expired on 03/31/2012. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.