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

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act (ACA).'' The matching program provides CMS with SSA data to use in determining individuals' eligibility to enroll in a qualified health plan through an exchange established under the ACA and for insurance affordability programs and certificates of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in this notice and associated web content to be published ahead of the hearing. The questions are intended to allow FDA to obtain stakeholders' perspectives on the impact of any future changes made to the length and format of the NDC.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.'' The document provides guidance regarding the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and other chronic uses.

This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also makes conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule includes changes to the Hospice Quality Reporting Program.

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. This final rule also alleviates administrative burden for IRFs by removing the Functional Independence Measure (FIM\TM\) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) beginning in FY 2020 and revises certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting beginning in FY 2019. Additionally, this final rule incorporates certain data items located in the Quality Indicators section of the IRF-PAI into the IRF case-mix classification system using analysis of 2 years of data beginning in FY 2020. For the IRF Quality Reporting Program (QRP), this final rule adopts a new measure removal factor, removes two measures from the IRF QRP measure set, and codifies a number of program requirements in our regulations.

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.

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 of our regulations regarding Food Additive Petitions and Investigational Food Additive Exemptions.

This final rule amends the definition of short-term, limited- duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum duration of short-term, limited-duration insurance, which will provide more affordable consumer choices for health coverage.

The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of Set 29 Draft Toxicological Profiles for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of Tribufos, Bromodichloromethane, Bromomethane, and 2-Hexanone for review and potential inclusion in the profiles. Although ATSDR considers key studies for these substances during the profile development process, this document solicits any relevant, additional information. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR also seeks comments on the organization and format of the Toxicological Profile for Bromodichloromethane. In an effort to improve the usability of the profiles, ATSDR recently made content and organizational changes based on user feedback, as well as data identifying the most used profile content. Changes include: Removing redundant content; adding summary figures and tables to Chapters 1, 2, 5, and 6 that did not exist in previous Toxicological Profiles; and reformatting the Levels of Significant Exposure (LSE) tables in Chapter 2. ATSDR has only applied the changes to the Draft Toxicological Profile for Bromodichloromethane, but intends to use the new format for future profiles. Specifically, ATSDR would like to know: (1) Does the chapter organization make it easier for you to find the information you need? For example, are you satisfied with the organization of the health effects chapter by organ system rather than exposure route? (2) Are the new tables and figures clear and useful? Do they make the Toxicological Profile easier to read? (3) If you have previously used any Toxicological Profile(s) for your work, which parts or content are the most useful to you, and what do you use it for? (4) Does the profile contain all of the information you need? If no, please elaborate on what additional information would be helpful. (5) Is there information you would like to see in the profile that is not currently included? If yes, please elaborate on the additional information you would like to see in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to provide the best service to the public regarding public health.

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 FDA's Research and Evaluation Survey for the Public Education Campaign on Tobacco (RESPECT) among the Lesbian Gay Bisexual Transgender (LGBT).

The Division of Pediatric and Maternal Health, Office of Surveillance and Epidemiology, and Office of Pediatric Therapeutics, Food and Drug Administration (FDA or the Agency) are announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance.'' The purpose of this 1-day workshop is to provide a forum to gather information on the latest developments in pediatric pharmacovigilance from the perspective of various stakeholders and to expand the conversation to include the utility and challenges of emerging pharmacovigilance tools, including specific challenges associated with pediatric data tools.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2019.