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

The National Toxicology Program (NTP) announces the public workshop ``Shift Work at Night, Artificial Light at Night, and Circadian Disruption.'' The purpose of the workshop is to obtain external scientific input on topics important for informing the literature-based health hazard assessments conducted by the NTP's Office of the Report on Carcinogens (ORoC) and Office of Health Assessment and Translation (OHAT). This workshop is open to the public to attend in-person or by webcast. Information about the meeting and registration are available at (https://ntp.niehs.nih.gov/go/ workshop_ALAN).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The National Institute for Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration (MSHA) have approved the first large-capacity (Cap 3) closed-circuit escape respirator (CCER) for use in underground coal mining, under the NIOSH new regulatory standard. Accordingly, respirator manufacturers may continue to manufacture, label, and sell large-capacity CCERs approved under the former regulatory standard (those CCERs with a rated service time of greater than 50 minutes) for underground coal mining approved under the former regulatory standard until January 4, 2017.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify population health interventions that are scientifically proven to save lives, increase lifespans, and improve quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force (a) considers the findings of systematic reviews that assess the effectiveness and economics of community preventive services, programs, and policies, and (b) issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (The Community Guide).

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, section 640(l)(4)].

This notice provides information on the National Institutes of Health's (NIH) reassessment of the need to maintain a colony of 50 chimpanzees for future research and decision to no longer maintain a chimpanzee colony for research. This notice also provides information on conforming updates and procedures related to this action.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.