Department of Health and Human Services October 7, 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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, 2011 (76 FR 46307) and allowed 60-days for public comment. No public comment were received. 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: A Generic Submission for Theory Development and Validation (NCI). Type of Information Collection Request: NEW. Need and Use of Information Collection: In order to carry out NCI's legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Data collections that result from this generic clearance would inform and clarify the use of theory in BRP-supported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: (1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; (2) Develop and refine integrative theories; (3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and (4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Frequency of Response: Will be determined by each project. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Members of the public including, but not limited to health professionals, physicians, and researchers. Table 1 outlines the estimated burden hours and cost required for a three-year approval of this generic submission.

This notice announces the establishment of the Medicare Economic Index Technical Advisory Panel and discusses the group's purpose and charter. It also requests nominations for individuals to serve on the panel.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 12, 2011 (76 FR 56200). The document announced that an information collection had been approved by the Office of Management and Budget (OMB). The document was published with an incorrect expiration date. This document corrects that error.

This document adopts the Countermeasures Injury Compensation Program Administrative Implementation Interim Final Rule as the final rule with technical amendments. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this final rule to adopt the administrative policies, procedures, and requirements for the CICP set out in the interim final rule, which was published and effective on October 15, 2010. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary makes only minor technical amendments to the interim final rule, described below, and otherwise adopts the regulation as published on October 15, 2010.