Department of Health and Human Services May 1, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Expedited Programs for Serious ConditionsDrugs and Biologics'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH eSubmissions Pilot Program (eSubmissions Pilot), which will be a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without the requirement for submitting a hard copy or a compact disc. Participation in the eSubmissions Pilot is open to applicants whose device submissions would be reviewed in either of two branches in CDRH's Office of Device Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the Peripheral Interventional Devices Branch, and is limited to unbundled, traditional 510(k) submissions for classified devices only. The eSubmissions Pilot will use the existing eSubmitter software for data acquisition and the existing Electronic Submission Gateway (ESG) for submitting (the eSubmissions Pilot is not intended to evaluate the existing eSubmitter software or the existing ESG). The eSubmissions Pilot is intended to provide industry and CDRH staff the opportunity to evaluate the 510(k) eSubmission with regards to the content (wording of questions, help text and guides), layout, and flow of the questions.

The Food and Drug Administration (FDA) has determined the regulatory review period for YERVOY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, FDA is proposing to reclassify urogynecologic surgical mesh instrumentation from class I to class II. The Agency is also proposing to establish special controls for surgical instrumentation for use with urogynecologic surgical mesh. FDA is proposing this action, based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance. The Agency is reclassifying both the surgical mesh for transvaginal repair and the urogynecologic surgical mesh instrumentation on its own initiative based on new information.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 27, 2014 (79 FR 17156). The document announced an opportunity to request a hearing on the Agency's proposal to withdraw approval of abbreviated new drug applications (ANDAs) from multiple sponsors. The document incorrectly stated that the approval of ANDAs 40825, 40822, and 40824, held by Ranbaxy Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540, and ANDA 40182, held by Pharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605, had not been voluntarily withdrawn. FDA confirms that the approval of ANDAs 40825, 40824, 40822, and 40182 has been voluntarily withdrawn.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Providing Information about Pediatric Uses of Medical Devices.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).