Department of Health and Human Services February 26, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has updated this guidance to implement the waiver improvements section of the 21st Century Cures Act (the Cures Act), which requires FDA to revise ``Section V. Demonstrating Insignificant Risk of an Erroneous ResultAccuracy'' of the guidance ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was issued on January 30, 2008. The remainder of the 2008 CLIA Waiver Guidance, with exception of technical edits for consistency with the newly amended section V, has not been substantively changed. This final guidance provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver and includes FDA's revised thinking regarding ``the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.''

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the opening of a docket to obtain comment on the DRAFT Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria, Group A Streptococcus, Meningococcal Disease, and Pertussis Sections (``Draft Guideline''). The Draft Guideline updates four sections of the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and their corresponding recommendations in Part II of the 1998 Guideline: ``4. Diphtheria;'' ``9. Meningococcal Disease;'' ``12. Pertussis;'' and ``18. Streptococcus, group A infection.'' The updated recommendations in the Draft Guideline are intended for use by the leaders and staff of Occupational Health Services (OHS) to facilitate the provision of occupational infection prevention and control (IPC) services to healthcare personnel (HCP) for the management of exposed or infected HCP who may be contagious to others in the workplace.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Laparoscopic Power Morcellators.'' This draft guidance proposes updated ``Contraindications'' and ``Warnings'' in product labeling information to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). This draft guidance is not final nor is it in effect at this time.

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.