Department of Health and Human Services July 28, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for substances prohibited for use in animal food or feed.

The Food and Drug Administration (FDA) has conducted a reorganization to modify its structure, to align similar functions under common executive leadership, and to reduce and change the reporting relationships to the Agency head. The reorganization creates four ``directorates'' within which most of FDA's activities will resideAdministrative operations, food and veterinary medicine, medical products and tobacco, and foreign and domestic regulatory operations. However, this restructuring will not change the basic form of FDA's programs, which will continue to reside in the Agency's seven operating Centers and the Office of Regulatory Affairs. It is intended to provide a more efficient span of control for executive leadership and to organize like activities together, not to change the essential programmatic activities under which FDA implements the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration (FDA) is considering factors affecting the reprocessing of reusable medical devices, including reprocessing quality, device design as it relates to the reprocessing of reusable medical devices, reprocessing methodologies, validation methodologies, and health care facility best practices. This is part of an ongoing effort to address patient exposure to inadequately reprocessed reusable medical devices. FDA would like to provide another opportunity for public comment by establishing a docket to receive information and comments from the public on factors affecting the reprocessing of reusable medical devices.

The Food and Drug Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and Research (CDER) to addressing drug shortages. This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help in developing topics for further discussion with industry and professional societies, and other stakeholders and may help the Agency to better address drug shortage issues. Date and Time: The public workshop will be held on September 26, 2011, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at 10903 New Hampshire Ave., Bldg. 31, rm. 1503 B and C (Great Room), Silver Spring, MD 20993. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https:// www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for You,'' click on ``White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.'' Please note that visitors to the White Oak Campus must enter through Building 1. (https://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.ht m). Contact Persons: Christine Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6202, Silver Spring, MD 20993-0002, 301- 796-1300 or 301-796-1600. Registration: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to dsworkshop@fda.hhs.gov by September 19, 2011. Persons without access to the Internet can call Christine Moser at 301-796-1300 or Lori Benner at 301-796-1300 to register. Registration is free for the public workshop. Seating will be available on a first-come, first- served basis. Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Lori Benner (see Contact) at least 7 days in advance.