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

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Depression in Children: Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2018.

The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC, a roster of members, the meeting agenda, as well as past meeting summaries is located on the ACHDNC website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.ht ml.

The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. We are taking this action in response to a food additive petition filed by the Juice Products Association.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

Administration for Children and Families, Office of Refugee Resettlement, announces the intent to issue an OPDIV-Initiated Supplement in multiple installments to BCFS Health and Human Services, San Antonio, TX. The aggregate total of the multiple installments will not exceed $367,860,381. The first two installments will be issued prior to September 30, 2018. The remaining installments will be issued after September 30, 2018 on to be determined dates. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 3,800 beds in an expedited manner.

The Food and Drug Administration (FDA or we) is confirming the effective date of July 10, 2018, for the final rule that appeared in the Federal Register of June 7, 2018, and that amended the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery.

The Secretary's National Advisory Council on Migrant Health (NACMH) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on the NACMH website at: https:// bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/ index.html.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Using Social Media for Recruitment in Cancer Prevention and Control Survey-Based Research (SMFR) project. The SMFR project aims to better understand how individuals at high-risk for cancer discuss risk and genetic testing with their families, while evaluating the feasibility of using social media to conduct survey-based cancer prevention and control research for survey recruitment.

The Administration for Children and Families (ACF) is proposing an additional data collection activity as part of the Evaluation of Employment Coaching for TANF and Related Populations. The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs approved this information collection in March 2018 (0970-0506). ACF is proposing a second follow-up survey conducted as part of the evaluation. This study will provide an opportunity to learn more about the potential of coaching to help clients achieve self-sufficiency and other desired employment-related outcomes. It will take place over five years in the following employment programs: MyGoals for Employment Success in Baltimore, MyGoals for Employment Success in Houston, Family Development and Self-Sufficiency program in Iowa, LIFT in New York City, Chicago, and Los Angeles; Work Success in Utah; and Goal4 It! in Jefferson County, Colorado. Together, these programs will include Temporary Assistance for Needy Families (TANF) agencies and other public or private employment programs that serve low-income individuals. Each site will have a robust coaching component and the capacity to conduct a rigorous impact evaluation. This study will provide information on whether coaching helps people obtain and retain jobs, advance in their careers, move toward self-sufficiency, and improve their overall well-being. To meet these objectives, this study includes an impact and implementation study, as approved by OMB. This submission builds on the existing impact study, which randomly assigned participants to either a ``program group,'' who were paired with a coach, or to a ``control group,'' who were not paired with a coach. The effectiveness of the coaching will be determined by differences between members of the program and control groups in outcomes such as obtaining and retaining employment, earnings, measures of self-sufficiency, and measures of self-regulation. The proposed information collection activity is a second follow-up survey, which will be available to participants approximately 21 months after random assignment. The second follow-up survey will provide rigorous evidence on whether the coaching interventions are effective, for whom, and under what circumstances. Respondents: Individuals enrolled in the Evaluation of Employment Coaching for TANF and Related Populations. All participants will be able to opt out of participating in the data collection activities.

The Food and Drug Administration (FDA) has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between April 2, 2018, and September 14, 2018, on FDA's website but not presented at the September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

This document corrects a technical error in the meeting notice that appeared in the August 31, 2018 Federal Register titled ``Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018.''

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Update to the Centers for Disease Control and Prevention Infection Prevention and Control Recommendation Categorization Scheme (Draft Update). The Draft Update provides updated categories that specify the strength of CDC's Infection Prevention and Control Guideline Recommendations. The Draft Update also includes recommendation justification tables, a new component of the recommendation development process, that provide transparency into the considerations weighed when developing infection prevention and control recommendations.