Department of Health and Human Services February 25, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the report and Web site location where the Agency has posted the report entitled ``Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,'' developed by the National Medical Device Postmarket Surveillance System Planning Board. In addition, FDA has established a docket where stakeholders may provide comments.

The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the- counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.

The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employment Policy and Measurement. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment outcomes for individuals with disabilities.

The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Self- Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with serious mental illness (SMI) and co-occurring conditions.

The Food and Drug Administration (FDA or the Agency) is opening a docket to obtain information and comments on specific areas of public health concern for racial/ethnic demographic subgroup populations, focusing on certain disease areas where significant outcome differences may be anticipated. The Agency is seeking public input on identifying areas that can be addressed through regulatory science research.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

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 July 8, 2014, Vol. 79, page 38542 and allowed 60-days for public comment. One public comment was received on July 9, 2014. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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.