The U.S. Patent and Trademark Office (USPTO) seeks comments on the estimated time burdens of revisions to a currently approved information collection involving the credentials and qualifications of new or existing practitioners on its Register of Patent Attorneys and Agents. USPTO anticipates that it will take some 21,800 respondents each year three minutes to 40 hours to prepare the appropriate forms and submit them. The information is used to determine whether the applicant “is of good moral character and repute; has the necessary legal, scientific, and technical qualifications; and is otherwise competent to advise and assist applicants in the presentation and prosecution of patent applications.” Comments are requested by October 8, 2014.
The U.S. Food and Drug Administration requests comments on proposed draft guidance that addresses issues related to the development of drugs for Duchenne muscular dystrophy (DMD). The draft guidance was submitted to the agency in June 2014 by stakeholders in the DMD community, including Parent Project Muscular Dystrophy. The deadline for submissions is October 6, 2014.
The U.S. Food and Drug Administration (FDA) requests comments on changes to the estimated time burdens for a collection of information following its review of comments on draft guidance for industry titled “Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Drug products compounded in an outsourcing facility can qualify for exemptions from FDA approval requirements and certain labeling requirements, and those facilities electing to register must submit certain information to the agency. FDA revised the time burdens in response to comments on the draft guidance relating to the information collection, increasing its estimates of the number of outsourcing facilities that will be subject to the guidance. Comments are requested by September 26, 2014.