Department of Health and Human Services December 26, 2017 – Federal Register Recent Federal Regulation Documents

This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition, published in the Federal Register of September 21, 2017, revising food additive regulations to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.

The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830.

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 The National Survey of Family Growth (NSFG), designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive 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 an extension of the time period for the outcome evaluation of FDA's multicultural youth tobacco public education campaign, the addition of two rounds of data collection with the original youth surveyed for the outcome evaluation, and recruitment of new youth to participate in those two additional surveys.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SIVEXTRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to conduct a Challenge Competition in Fall 2018 to develop user-friendly technical tools to collect and integrate patient-reported outcome data in electronic health records or other health information technology products.