Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Medical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Request for Public Comment: 60 Day Notice for Extension of the Indian Health Service Loan Repayment Program
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' This previously approved information collection project was last published in the Federal Register (80 FR 23558) on April 28, 2015, and allowed 60 and 30 days for public comment. No public comment was received in response to the notices. This notice announces our intent to submit this collection, which expires July 31, 2018, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
National Institute of General Medical Sciences Notice of Organizational Change
The National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) is seeking public comment regarding its proposal to reorganize and to rename its Center for Research Capacity Building to the Division for Research Capacity Building, and transfer the Office of Emergency Care Research to the National Institute of Neurological Disorders and Stroke.