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

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 ``Medical Office Survey on Patient Safety Culture Database.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on MicrosamplingQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question-and-answer (Q&A) guidance provides additional information to facilitate interpretation of the guideline for industry ``S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies and acknowledges the benefits (and some limitations) of the use of microsampling.

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 Health Message Testing System (HMTS). The Health Message Testing System (HMTS), a Generic information collection, that enables programs across CDC to collect the information they require in a timely manner.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that a webinar meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place and open to the public to listen in via a toll free number.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council of the National Health Service Corps (NACNHSC) will hold a public meeting.

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 Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Menu Labeling: Supplemental Guidance for Industry.'' The guidance addresses stakeholder concerns regarding the implementation of nutrition labeling required for foods sold in covered establishments, includes expanded and new examples of alternatives to aid in compliance, identifies places where we intend to be more flexible in our approach, and advises of our intent to exercise enforcement discretion regarding nutrient declaration for ``calories from fat'' as part of the additional written nutrition information. The guidance also includes many graphical depictions to convey our thinking on various topics and to provide examples of options for implementation, and addresses calorie disclosure signage for self-service foods, including buffets and grab- and-go foods; reasonable basis, and the criteria for considering the natural variation of foods, when determining nutrition labeling for such foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.

This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This rule also proposes to update the IPF labor- related share, to update the IPF wage index for FY 2019, update the International Classification of Diseases 10th Revision, Clinical Modification (ICD-10-CM) codes for FY 2019, make technical corrections to the IPF regulations, and update quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it would update providers on the status of IPF PPS refinements. Finally, this proposed rule includes a Request for Information related to health information technology.

This proposed rule would update 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 proposed 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. We are also proposing to alleviate administrative burden for IRFs by removing the Functional Independence Measure (FIMTM) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) and revising certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting. In addition, we are soliciting comments on removing the face-to-face requirement for rehabilitation physician visits and expanding the use of non-physician practitioners (that is, nurse practitioners and physician assistants) in meeting the IRF coverage requirements. For the IRF Quality Reporting Program (QRP), we are proposing to adopt a new measure removal factor, remove two measures from the IRF QRP measure set, and codify in our regulations a number of requirements.

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. HRSA published the 60-day notice on December 15, 2017, FR Doc. 2017-27013. HRSA received one comment. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Precision IBD, Inc., located in San Diego, California, and incorporated under the laws of Delaware.

The Food and Drug Administration (FDA) published in the Federal Register of January 26, 2018, a direct final rule to amend the general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

We are proposing to revise 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 2019. Some of these proposed changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are proposing to provide the market basket update that would apply to the rate[dash]of[dash]increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2019. We are proposing to update 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 2019. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS[dash]exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are proposing changes to the requirements that apply to States operating Medicaid Promoting Interoperability Prrograms. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to make changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.