Department of Health and Human Services January 9, 2018 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) announces the Adapting Clinical Guidelines for the Digital Age meeting. Adapting Clinical Guidelines for the Digital Age is an initiative to improve patient care and health outcomes by working to ensure that clinical guidelines are not only evidence-based but also are used in practice. Because there are multiple roles in developing and disseminating clinical guidelines, it is important to get a comprehensive understanding of the current challenges in translating guidelines in order to develop a standardized process for the future. The meeting will use the Kaizen approach to ensure stakeholder perspectives and experiences along the clinical guideline continuum are collected. Kaizen focuses on continuous improvement by bringing together stakeholders to gather individual perspectives and experiences so that improvements can be made to a specific area of focus in a process. Additional information about Kaizen is available at the Electronic Clinical Quality Improvement Resource Center website (https:// ecqi.healthit.gov/ecqi/kaizen). The scope of the meeting will encompass the following: Gathering individual perspectives and experiences about guideline creation and summarizing the evidence; informatics framework for guideline translation; dissemination modalities and communication methods; translation and implementation support; and evidence.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory's result as their own. This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions. We intend to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.