Department of Health and Human Services August 14, 2019 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.

The Food and Drug Administration (FDA or Agency) is announcing its intention to begin inactivating drug listing records that are improperly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently registered with FDA. FDA's regulations governing drug establishment registration and drug listing require registrants to notify FDA if commercial distribution of a listed drug is discontinued. They also require firms to submit drug listing updates if any material changes are made to information previously submitted, including a change in manufacturing establishment(s). FDA has found that listings for many drug products do not comply with these regulations because they have not been updated in over a year, they have not been certified as being up to date, or they identify within the listing information at least one manufacturing establishment that is not currently registered with FDA. Many of the drugs that are the subject of these listings appear to no longer be in commercial distribution. The purpose of this notice is to remind registrants of their legal obligations and announce that, if drug listings are not appropriately updated, certified, or associated with a registered establishment, they will be marked by FDA as ``inactive,'' and the date of inactivation will be added to the listing record. This process will result in the closure of drug records in all public drug listing databases maintained by FDA, including the National Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file, until corrections to the relevant listings are made.

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: ``Safety Program in Perinatal Care (SPPC)II Demonstration Project.'' This proposed information collection was previously published in the Federal Register on May 1, 2019, and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations.