Department of Health and Human Services June 5, 2018 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On May 7, 2018, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2019. HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The previous guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued on November 18, 2015, has been withdrawn.

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

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. A 60-day Federal Register Notice was published in the Federal Register on February 9, 2018 (83 FR 5791). There were 23 public comments. 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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 125 ports available. Due to the limited accommodations by phone ports and room size, we are encouraging the public to please register using the link https://www.surveymonkey.com/r/CMNSX73. There will be a public comment period from 11:10 a.m.-11:40 a.m., on June 19, 2018, and from 11:30 a.m.-11:45 a.m., on June 20, 2018. All public comments will be limited to two-minutes per speaker.

This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.