Department of Health and Human Services February 25, 2016 – Federal Register Recent Federal Regulation Documents

This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and Children's Health Insurance Program (CHIP) consumer education strategies. This meeting is open to the public.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0004. The ICR will expire on August 31, 2016. Grants.gov also requests categorizing this form as common forms, 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. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

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 December 15, 2015, pages 77647-77648 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH Clinical Center (CC), 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. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Robert M. Lembo, MD, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health, 10 Center Drive, Room 1N252C, Bethesda, MD 20892- 1158, or call non-toll-free number (301) 496-2636, or Email your request, including your address to: robert.lembo@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research, Revision OMB#0925-0602 Expiration Date: 3/31/16, Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The information collected will allow continued assessment of the value of the training provided by the Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center and the extent to which this training has promoted: (a) Professional competence; (b) research productivity and independence; and (c) future career development within clinical, translational, and academic research settings. The information received from respondents is presented to, evaluated by, and incorporated into the ongoing operational improvement efforts of the Director of the OCRTME and the Director, NIH Clinical Center. This information will continue to support the ongoing operational improvement efforts of the OCRTME and its commitment to provide clinical research training and medical education of the highest quality to each trainee at the NIH Clinical Center. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hour total is 320.

The Food and Drug Administration (FDA), in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC), is announcing a public workshop entitled ``Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.'' The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers. The 2-day workshop will focus on the standards relevant to the qualification of a range of safety biomarkers and examine case studies in several different organ systems.