Department of Health and Human Services February 26, 2018 – Federal Register Recent Federal Regulation Documents

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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on December 22, 2017 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

HRSA is seeking nominations of four qualified candidates to be considered for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (Committee). The Committee consists of 18 public members, including two co-chairs. The Committee membership maintains a balance of diverse experiences and expertise. Those requesting consideration require expertise in areas such as: Public health; epidemiology; laboratory practice; immunology; infectious diseases; behavioral health and science including, but not limited to opioid use and related expertise; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. In addition, people living with HIV and affected populations as well as individuals employed by state and local health and education agencies, HIV/viral hepatitis/STD community-based organizations, and the ethics or religious community are encouraged to submit nomination packages for consideration. Current federal employees will not be considered.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following website: https://www.hrsa.gov/ advisorycommittees/childhoodvaccines/.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Promoting the Use of Complex Innovative Designs in Clinical Trials.'' The topic to be discussed is the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making. This meeting will inform development of a guidance document as required by the 21st Century Cures Act (Cures Act) and is being conducted to meet the performance goal of convening a public workshop on CID included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA). This meeting will also inform the development of a CID pilot program. FDA is seeking comments on the use of CID to inform regulatory decision making and is also seeking input on the CID pilot program.