Department of Health and Human Services April 13, 2017 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection project entitled ``Assessing School-Centered HIV/STD Prevention Efforts in a Local Education Agency.'' This study provides in-depth assessment of Human Immunodeficiency Virus (HIV) and Sexually Transmitted Disease (STD) prevention efforts in a location education agency funded by CDC's Division of Adolescent and School Health.

The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled ``Regulation of Intentionally Altered Genomic DNA in Animals'' that was announced in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the class I devices included in this document. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.