Department of Health and Human Services March 15, 2019 – Federal Register Recent Federal Regulation Documents

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 of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 80 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see Contact Person for More Information) no later than 12:00 noon (EDT) on Thursday, April 18, 2019:

HHS gives notice of a decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by the space available. The meeting room will accommodate up to 60 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100). Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, April 15, 2019. Persons who desire to make an oral statement, may request it at the time of the public comment period on April 16, 2019 at 3:20 p.m. EDT.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.'' The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. This guidance defines several types of enrichment strategies, provides examples of potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. This guidance finalizes the draft guidance entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products'' issued on December 17, 2012.

This document corrects technical errors in the ``Evaluation and Management Services'' provisions that appeared in the final rule with comment period published in the Federal Register on November 23, 2018, concerning changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.

Sexual and gender minority (SGM) is an umbrella phrase that encompasses lesbian, gay, bisexual, and transgender populations as well as those whose sexual orientation, gender identity and expressions, or reproductive development varies from traditional, societal, cultural, or physiological norms. This includes Disorders or Differences in Sex Development (DSD), sometimes known as intersex. The Sexual & Gender Minority Research Office (SGMRO) at the National Institutes of Health (NIH) has developed the document ``Methods and Measurement in Sexual & Gender Minority Health Research: Identifying Research Opportunities'' pertaining specifically and exclusively to methods and measurement research in SGM health research. Experts in the field identified research opportunities related to methods and measurement in SGM health research during a workshop held in the Spring of 2018. The document reflects the content of the discussion among participants at the Methods and Measurement in SGM Health Research Workshop and does not represent an official position of NIH or any other government agency. We would like to obtain comment on the specifics of this document to consider for the purposes of informing and enhancing its content.