Department of Health and Human Services January 28, 2013 – Federal Register Recent Federal Regulation Documents

The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) are announcing the end of support for the 3.1.1. version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since October 2009, is the newer standard supported by FDA. Support for SDTM IG 3.1.1 will end on January 28, 2015.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Devices and Radiological Health (CDRH) radiation protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State, and Tribal activities to achieve effective solutions to present and future radiation control problems. The recipient of this cooperative agreement award will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems. The recipient will also plan and facilitate an annual meeting and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. The recipient will establish committees, in accordance with Federal statutes and regulations, to address, evaluate, and propose solutions for a wide range of radiation health and protection issues. Examples of relevant areas already identified to be of interest include, but are not limited to: (1) The application of x-rays to the healing arts; (2) the application of non-medical ionizing radiation and medical/non- medical non-ionizing radiation; and (3) the control and mitigation of radiation exposure from all sources.

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 for extending the use of the approved information collection assigned OMB control number 4040-0001, which expires on March 31, 2013. 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.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a time-limited work group and a standing work group to be convened by an AHRQ contractor. The work groups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the Qls. The time- limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.