Department of Health and Human Services September 22, 2014 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) 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 community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' 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 considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations 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 (Community Guide).

The Food and Drug Administration (FDA) is announcing a public scientific workshop to discuss the roadmap for applying regulatory science to neonates. This public scientific workshop is being co- sponsored with the FDA, the Critical Path Institute (C-Path) and the Burroughs Welcome Fund (BWF). The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics.

The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for any other purposes, a preamendments class III device, into class II (special controls), and to amend the device identification. FDA is proposing this reclassification on its own initiative based on new information. This action implements certain statutory requirements.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance on Estradiol.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ [has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This proposed information collection was previously published in the Federal Register on June 4th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.