Department of Health and Human Services April 2, 2008 – 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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.

The Food and Drug Administration (FDA) is announcing that it is establishing a public docket to receive information and comments related to its comprehensive Food Protection Plan (the Plan) released in November 2007. The new Plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. FDA is establishing this docket for the purpose of soliciting comments from its stakeholders on the Plan and the questions set forth in this notice.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the proposed national survey of healthcare workers' safety and health and a proposed national survey of employer safety and health practices. Public Comment Period: April 2, 2008 through July 1, 2008. Public Meeting Time and Date: 8 a.m.-4:30 p.m. EDT, April 30, 2008. Place: Sheraton Cincinnati Airport Hotel, 2826 Terminal Drive, Hebron, Kentucky 41048, (859) 371-6166. Purpose of the Meeting: To obtain public comment on the content and conduct of a survey of healthcare workers' safety and health practices and a separate survey of healthcare establishment's safety and health practices. Special emphasis will be placed on discussion of the following: (1) Content of the survey questionnaires; (2) Appropriate methods of conducting the surveys. Status: The forum will include scientists and representatives from industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 60 people. Interested parties should make hotel reservations directly with the Sheraton Cincinnati Airport Hotel by calling toll free (888) 627-8418 before the cut-off date of 5 p.m. EDT April 8, 2008. A special group rate of $95 per night plus tax for meeting guests has been negotiated for this meeting. In order to receive the special room rate, you will need to indicate that you will be attending the NIOSH meeting. Interested parties should confirm their attendance to this meeting by contacting Ms. Kim Collins, meeting coordinator, at 513-841-4211 or kycollins@cdc.gov by April 15, 2008. Oral comments given at the meeting will be recorded and included in the NIOSH docket number 135. Written comments, including prepared oral comments, will also be accepted at the meeting or by submitting to the NIOSH Docket Office (see address below). Background: The goal of the healthcare worker survey is to collect information describing hazards, exposures, safety and health practices, and use of exposure controls by occupation and type and size of establishment. The goal of the management survey is to collect information describing facility-based health and safety resources, safety and health management programs, policies and practices for the same health and safety hazards covered in the worker survey, by type and size of establishment. Preliminary work on this effort included a feasibility study which was completed in 2006. The study assessed the feasibility of collecting self-reported information on health and safety practices from healthcare workers at their workplace. Worker and management questionnaires were developed (based on healthcare stakeholder input) and refined using focus groups/cognitive interviews, and pilot-tested at two large medical centers. Based on the pilot test findings, NIOSH decided that it would be more cost-effective to implement the worker survey as a web-based survey through various professional and labor organizations, rather than through employer establishments. The management questionnaire will be targeted to individuals responsible for facility health and safety, based on a representative sample of healthcare establishments. Although the content of the questionnaires has been fairly well-defined, information will be sought from meeting participants on other important or emerging healthcare safety and health issues for possible inclusion in the questionnaires, as well as other information (see below). The proposed worker and management questionnaires may be found at: https://www.cdc.gov/niosh/review/public/ 135. Contact Person for Technical Information: Jim Boiano (513) 841- 4246, or Karl Sieber (513) 841-4231. Comments on the topics presented in this notice and at the meeting should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio, 45226, (513) 533-8611 or fax (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov or at https:// www.cdc.gov/niosh/review/public/135. All electronic comments should be formatted in Microsoft Word. All material submitted to the Agency should reference the NIOSH Docket number 135 and be submitted by July 1, 2008. After the comment period has closed, comments will be able to be accessed electronically at https://www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations and other information, on the Internet. Reference: The proposed worker and management questionnaires may be found at: https://www.cdc.gov/niosh/review/public/135.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare, LLC. The supplemental NADA provides for the use of enrofloxacin injectable solution in female dairy cattle less than 20 months of age.