Department of Health and Human Services April 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The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled ``Regulation of Intentionally Altered Genomic DNA in Animals'' that was announced in the Federal Register of January 19, 2017.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.

This notice announces the meeting dates for the Technical Advisory Panel on Medicare Trustee Reports on Tuesday, May 2, 2017 and Wednesday May 3, 2017 in Washington, DC

On September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. CDC received two comments, both of which supported the rule change.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries, which is currently being conducted by the AHRQ's Evidence-based Practice CentersProgram. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will hold a public meeting on April 12, 2017, and a joint public meeting with the National Advisory Committee on Children and Disasters (NACCD) on April 13, 2017. Notice of publication for the April 12-13, 2017 meeting is less than 15 calendar days prior to the meeting, as exceptional circumstances exist. Pursuant to the Federal Advisory Committee Management Regulations, the notice for this meeting is given less than 15 calendar days prior to the meeting due to exceptional circumstance. It is imperative that the National Preparedness and Response Science Board (NPRSB) and the National Advisory Committee (NACCD) hold this April 12-13, 2017 meeting to accommodate the scheduling priorities of key participants. Given HHS's need for the NPRSB and NACCD's ongoing advice, and the scheduling difficulties of selecting alternative dates, the agency deems it important for the advisory committees to meet on April 12-13, 2017, despite the late notice.