The U.S. Patent and Trademark Office solicits comments on the estimated time and cost burdens of the revision of a currently approved collection of information involving patent petitions “that must be accompanied by the petition fees set forth in 37 CFR 1.17(f ), (g), or (h).” Comments must be submitted by July 21, 2014.
The U.S. Food and Drug Administration requests comments by July 7, 2014, on the time and cost burdens of a proposed information collection for the “Prescription Drug Labeling and Enhancement Initiative,” which is intended to “enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling.” The agency specifically seeks input on “information collection associated with the use of Government contractor-assisted labeling conversion resources and services for certain older drug and biological products (approved before June 20, 2001).”
The U.S Food and Drug Administration (FDA) issues draft guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” Intended to provide information about “the appropriate use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices,” the document discusses, among other things, “procedures for the appropriate use of consensus standards, both recognized and non-recognized, limitations on the use of consensus standards, and the content of a Declaration of Conformity to FDA recognized consensus standards.” Comments are requested by August 11, 2014.
The U.S Food and Drug Administration (FDA) issues draft guidance titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” which discusses “critical considerations related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials.” This document is one in a series that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. Comments are requested by August 12, 2014.
The Department of Commerce requests comments by July 18, 2014, on the estimated time burdens of a proposed information collection concerning the distribution of expenses incurred by recipients of biomedical research awards from the National Institutes of Health. The agency plans to use the information, along with wage and price data from other published sources, to create the Biomedical Research and Development Price Index. Comments are requested by July 18, 2014.
The U.S Food and Drug Administration (FDA) announces an October 8-9, 2014, workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3–D Printing,” for the purpose of providing “a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3–D printing.” Registration is requested by September 30, and comments should be submitted by November 10.