Department of Health and Human Services June 11, 2018 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, this notice announces a public meeting of the Council on Graduate Medical Education (COGME). This notice is being published less than 15 days prior to the meeting date due to unforeseen administrative delays.

The National Institutes of Health (NIH) is informing the research community and other interested parties that it received from the NIH Council of Councils the report of its Working Group on Assessing the Safety of Relocating At-Risk Chimpanzees, and the agency will consider recommendations contained in the report (see https:// dpcpsi.nih.gov/sites/ default/files/CoC_May_2018_WG_Report_508.pdf). The NIH invites public comment in response to this Request for Information (RFI).

The Food and Drug Administration (FDA) is announcing the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2020.

The Food and Drug Administration (FDA or Agency) has determined that MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/ vial and 20 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory requirements are met.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.