Department of Health and Human Services August 2019 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed new information collection and solicits comments on the information collection requirements related to the ``Adult Protective Services Client Outcome Study''.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities.'' The purpose of the public workshop is to highlight the work FDA has been doing to support and implement FDA's Predictive Toxicology Roadmap.

The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data on the condition and ownership of American Indian and Alaska Native (AIAN) facilities to meet congressional reporting requirements under the Head Start Act.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Lyell Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.

The Administration for Children and Families (ACF) is requesting a three-year extension of 20 previously approved forms that include satisfaction surveys; a leadership interview protocol; a web- based collaboration survey; assessment tools; and service-specific feedback forms (OMB #0970-0484, expiration 8/31/2019). There are no changes to these forms. An extension is not being sought for four instruments originally included (Tribal Organizational Assessment Interviews: Caseworker Interview; Community Provider Interview; Community Member/Elder Interview; Family Interview).

Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on October 4, 2019. The purpose of the meeting is for the Committee to discuss its work on its interim report on recommended best practices for states to follow to combat the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models, and programs. The members of the Committee request any examples and comments from the public to inform their work and have also requested input on the following specific topics pertaining to combating the sex trafficking of children and youth in the United States: Screening and Identification: Intersections with interpersonal violence; screening or universal approaches. Service Provision: Models for multi-agency response protocols; evaluated training curricula for service providers; case management and specialized service models. Housing: Prevention efforts of public housing authorities. Prevention: Initiatives of city, county, and state public health departments. Data: Strategies for state Medicaid offices to collect quality measures regarding violence or exploitation; collection and protection of exploitation data in health records. Child Welfare: Evidence-informed or -based curricula for child welfare providers, child and youth service providers, and foster parents; child welfare policies and procedures for identifying and responding to trafficking; interagency data sharing agreements that pertain to child sex trafficking cases; specialized foster care models including residential treatment; screening tools used in child welfare agencies and whether or not they've been validated. State funding sources for prevention, training, and/or services in addition to federal non-IV-E funding. Please submit your examples and/or comments to adonald@nhttac.org with the subject ``NAC Comments'' as soon as possible and before August 30.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription 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 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with Agency guidance entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' The guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACET. The ACET consists of 10 experts in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. They are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). ACET provides advice and recommendations regarding eliminating tuberculosis (TB) to the Secretary, HHS; the Assistant Secretary for Health, HHS; and the CDC Director. ACET (a) makes recommendations regarding TB prevention and control policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of ACET's objectives. Nominees will be selected on the basis of their expertise in public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. Federal employees are ineligible for membership. Members may be invited to serve for up to four year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACET's objectives.

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.

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.

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 information collection project ``Systematic Review Data Repository.'' This proposed information collection was previously published in the Federal Register on June 14, 2019 and allowed 60 days for public comment. There were no substantive comments received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2020 and to implement certain recent legislation. We also are making changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2020. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020. In this FY 2020 IPPS/LTCH PPS final rule, we are addressing wage index disparities impacting low wage index hospitals; providing for an alternative IPPS new technology add-on payment pathway for certain transformative new devices and qualified infectious disease products; and revising the calculation of the IPPS new technology add-on payment. In addition, we are revising and clarifying our policies related to the substantial clinical improvement criterion used for evaluating applications for the new technology add-on payment under the IPPS. We are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements and revising existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.

The Food and Drug Administration (FDA or we) 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.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions found in Agency regulations pertaining to the protection of human subjects and responsibilities of institutional review boards (IRBs).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Child- Resistant Packaging Statements in Drug Product Labeling.'' This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child- resistant packaging (CRP) statements in prescription and over-the- counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), in the Office of the Director, the National Institutes of Health (NIH) is streamlining the electronic system for the submission and processing of requests for NIH to issue Certificates of Confidentiality (CoCs).

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.