Department of Health and Human Services June 24, 2019 – Federal Register Recent Federal Regulation Documents

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is updating its Strategic Plan for Fiscal Years (FY) 2020-2024 to help guide the research it supports over the next five years. The Institute issued a previous Request for Information (RFI) (NOT-AR-19-009) to solicit initial comments on how the previous plan for Fiscal Years 2015-2019 should be modified to reflect progress over the past five years. The Institute also gathered additional input through listening sessions with the community. Based on this feedback, along with input from the NIAMS Advisory Council and its Working Group for the Strategic Plan, the Institute has drafted the NIAMS Strategic Plan for FY 2020-2024. We are now seeking input on this draft. Through this RFI, NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public on the draft NIAMS Strategic Plan for FY 2020-2024. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. The final draft of the Strategic Plan will be presented at the September 2019 meeting of the NIAMS Advisory Council and the final plan will be posted on the NIAMS website once it is approved.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZOLGENSMA (onasemnogene abeparvovec-xioi), manufactured by AveXis, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This guidance outlines the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. This guidance finalizes the draft guidance issued in April 2015.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.