Department of Health and Human Services March 1, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.'' This public meeting is intended to obtain patients' and caregivers' perspectives on impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. Developing a treatment for a rare disease can present unique challenges, such as the small number of individuals affected and heterogenous etiologies and manifestations. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases. The goal of this meeting is to identify common issues and symptoms in rare diseases to help advance medical product development, potentially through the creation of novel endpoints or trial designs that focus on commonalities across a variety of rare diseases.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enforcement Policy for Certain Marketed Tobacco Products.'' FDA is issuing this draft guidance to provide information regarding FDA's enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE) order. This policy primarily involves ``provisional'' tobacco products that become subject to NSE orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (provisional tobacco products are tobacco products that were first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence report (SE Report) was submitted no later than March 22, 2011). The draft guidance also provides information on FDA's enforcement policy when an applicant files a request for supervisory review of an NSE order.

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.

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2019 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.