Department of Health and Human Services September 17, 2018 – Federal Register Recent Federal Regulation Documents

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled ``Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.'' This guidance explains our current thinking on how to determine whether a facility is a ``qualified facility'' that is subject to modified requirements under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' (the Preventive Controls for Human Food Rule) or under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' (the Preventive Controls for Animal Food Rule). This guidance also explains our current thinking on how a facility would submit Form FDA 3942a, attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b, attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from medical specialty groups and/or medical experts regarding compounded drug products that contain certain bulk drug substances to support establishment of a list of bulk drug substances under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Pathogen Reduction Technologies for Blood Safety.'' The purpose of the public workshop is to foster the development and implementation of pathogen reduction technologies for blood components intended for transfusion. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) proposes to collect information as part of the TANF Data Innovations (TDI) project. TDI is an investment to expand the integration, analysis, and use of TANF data to improve program administration, payment integrity, and outcomes for participants. TDI will start by assessing the needs and readiness of TANF agencies across the country to set up and operate data systems to support program improvement. A key goal of the needs assessment is to help categorize states' readiness to effectively use data and produce evidence. Informed by this assessment and discussions with key stakeholders, TDI will support a broad learning collaborative of state agencies and other entities related to the TANF program, including a range of Technical Assistance (TA) options to help states improve their use of TANF and other program data. This information collection request will consist of a needs assessment survey to be completed by state TANF agency administrators and staff to gather detailed information about their capacities and needs. These data will help HHS to better understand the challenges and barriers states face in using data and research to inform program decision-making, and they will help the TDI team design future technical assistance activities for TANF agencies to address states' challenges. Respondents: State TANF Administrators and TANF agency staff. We expect four respondents per state or territory.

The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), proposes to modify or alter an existing system of records subject to the Privacy Act, System No. 09- 70-0541, titled ``Medicaid Statistical Information System (MSIS).'' This system of records covers the Medicaid dataset. The dataset includes standardized enrollment, eligibility, and paid claims of Medicaid recipients and is used to administer Medicaid at the Federal level, produce statistical reports, support Medicaid related research, and assist in the detection of fraud and abuse in the Medicare and Medicaid programs. CMS is adding two new routine use as numbers three and 10. CMS is including two routine uses that were published on February 14, 2018, and are numbered as eight and nine in the routine use section below. In addition, CMS is changing the name of the system of records to: Transformed-Medicaid Statistical Information System (T- MSIS) and making other modifications which are explained below.