Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
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.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
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.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction
The Food and Drug Administration is correcting a notice entitled ``Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The document was published with the incorrect docket number. This document corrects that error.
Announcement of Intent To Issue an OPDIV-Initiated Supplement Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
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.
Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date
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.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
The Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT) has scheduled a public meeting. Information about the CHACHSPT can be found here: https://www.cdc.gov/maso/facm/ facmchachspt.html. An agenda may be requested by emailing CHACAdvisoryComm@hrsa.gov.
National Advisory Council on Migrant Health
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Behavioral Risk Factor Surveillance System (BRFSS), an annual state-based health survey that produces state-level information on health risk behaviors, health conditions, and preventive health practices that are associated with chronic diseases, infectious diseases, and injury.
Proposed Data Collection Submitted for Public Comment and Recommendations
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.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic 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.
Proposed Information Collection Activity
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.
Oakshire Naturals LP; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories.
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
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.
Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment titled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. To view the notice, document and related materials, visit https://www.regulations.gov and enter CDC-2016-0001 in the search field and click ``Search''.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018; Correction
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.''
Agency for Healthcare Research and Quality; Notice of Meetings
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.
Draft Update to the Centers for Disease Control and Prevention Infection Prevention and Control Recommendation Categorization Scheme
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.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October meeting, the Long-Term Services and Supports Subcommittee will be taking charge of the theme. The topics covered will include: (1) The experience of people with dementia who have special needs due to issues like diversity, geography, and concurrent disorders; (2) How clinical care can be better integrated with community-based supports and services; and (3) Evidence-based behavioral approaches that mitigate the impact of behavioral symptoms of dementia. The meeting will also include updates on work from the previous meetings and federal workgroup updates.
Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability
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.
Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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).