November 20, 2013 – Federal Register Recent Federal Regulation Documents

The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.

The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.

PHMSA and FRA are issuing this safety advisory as a follow-up to the agencies' joint safety advisory published on August 7, 2013 and FRA's Emergency Order No. 28 published that same day, both of which relate to the July 6, 2013, catastrophic accident in Lac- M[eacute]gantic, Quebec. In this safety advisory, PHMSA and FRA are reinforcing the importance of proper characterization, classification, and selection of a packing group for Class 3 materials, and the corresponding requirements in the Federal hazardous materials regulations for safety and security planning. In addition, we are reinforcing that we expect offerors by rail and rail carriers to revise their safety and security plans required by the Federal hazardous materials regulations, including the required risk assessments, to address the safety and security issues identified in FRA's Emergency Order No. 28 and the August 7, 2013, joint Safety Advisory.

The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3646), entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food'' and its information collection provisions.

The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place. The purpose of the meeting is to vote on the Committee's Annual Report and to receive briefings and updates relating to the Committee's current work.

NMFS is reallocating the projected unused amounts of the 2013 halibut and crab prohibited species catch (PSC) allowances from the Bering Sea and Aleutian Islands trawl (BSAI) limited access sector to the Amendment 80 cooperatives in the BSAI management area. This action is necessary to allow the Amendment 80 cooperatives to fully harvest their 2013 groundfish allocations.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation'' dated November 2013. The draft guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing 510(k) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion and transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.'' FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. The public workshop is being rescheduled due to the government shutdown. The title of the workshop has also been changed.

The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments on the draft guidance. We are taking this action to allow interested persons additional time to submit comments and to allow for public discussion at the February 25-26, 2014, Cellular, Tissue, and Gene Therapies Advisory Committee meeting, where FDA will present the draft guidance document for review.

The Commission is noticing a recently Postal Service filing concerning the Postal Service's intention to change rates of general applicability for competitive products. This notice informs the public of the filing, invites public comment, and takes other administrative steps.