Department of Health and Human Services May 23, 2013 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Vivian Horovitch-Kelley, PRA/OMB Project Clearance Liaison, Office of Management Policy and Compliance (OMPC), National Cancer Institute, 11400 Rockville Pike, Room 707, Rockville, MD 20852 or call non-toll- free number 301-480-0541 or Email your request, including your address to: Horovitchkellv@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Generic Clearance to Support Programs and Administrative Operations At the National Cancer Institute (NCI), 0925- NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for a new, generic submission that would be used for administrative and program-related submissions. Administrative submissions are defined as information collections (ICs) wherein the primary content is used for administrative purposes (e.g., an application) or to monitor or improve a program. These ICs may involve little if any, subsequent analysis and/or the use of simple, descriptive statistics. Some ICs are forms used to source and aggregate contact information, history, preferences, opinions, and/or other data that does not necessitate further inquiry but allow the respondents to maintain contact, indicate preferences, and respond to data calls of information that has not already been collected. Other ICs may be program-related requests for the purpose of monitoring, improving or assessing the effectiveness of the program. NCI program staff who have submitted sub-projects that have been reviewed and returned by OMB, have contributed ideas and comments to this request. Along with the analysis, NCI's ongoing education and outreach effort has increased the awareness and the need for the request of a generic, administrative and program-related information collection. NCI's current scope and capacity for administrative generic sub-studies is non-existent and this request would fill this gap. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,000.

This final rule implements new medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program established under the Patient Protection and Affordable Care Act.