Department of Health and Human Services March 5, 2014 – Federal Register Recent Federal Regulation Documents

This document extends the comment period for the Administrative Simplification: Certification of Compliance for Health Plans proposed rule, which was published in the January 2, 2014 Federal Register. The comment period for the proposed rule, which would have ended on March 3, 2014, is extended to April 3, 2014.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System'' dated March 2014. The guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. If unlicensed HPC, Cord Blood units are made available for clinical use, they must be distributed under an IND. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the final guidance entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated June 2011.

The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) will be moving its offices and laboratories from various Rockville and Bethesda, MD, locations to the FDA White Oak campus in Silver Spring, MD. The move will commence on or about May 1, 2014, and will end approximately 8 weeks later, on or about July 1, 2014. During this time persons may continue to send applications and other submissions electronically via the FDA Electronic Submissions Gateway to CBER for review, evaluation, or other handling. However, persons should send submissions on paper or on electronic media (CD, DVD), as well as lot release samples to CBER's new mailing addresses once they take effect. CBER's new mailing addresses, including the dates they take effect, as well as other information concerning CBER's move to the FDA White Oak campus in Silver Spring, MD, will be provided on the FDA Web site at https:// www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsan dTobacco/ CBER/ucm385240.htm, as they become available. During the period required for relocation of files, equipment, and Agency personnel, CBER will make every effort to meet its review time frames and minimize any potential delay. Should delays affecting receipt and review of applications and other submissions occur, we intend to update the FDA Web site as needed.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.