Department of Health and Human Services March 9, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA advisory committee members, and FDA staff, entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' We are issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand the public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The guidance provides additional transparency to FDA's advisory committee process beyond current guidance. This guidance finalizes the draft guidance of the same title dated March 2010 and replaces the guidance of the same title dated August 2008.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)-Preparation for ICCR-6 Meeting in Rockville, Maryland'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Rockville, MD. The topics to be discussed are the topics for discussion at the forthcoming ICCR Steering Committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Rockville, MD on July10 to 13, 2012. Date and Time: The meeting will be held on May 15, 2012, from 2 to 4 p.m. Location: The meeting will be held in the Washington Theater Room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: All participants must register with Kimberly Franklin, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, by email: Kimberly.Franklin@fda.hhs.gov or FAX: 301-595-7937. Registration and Requests for Oral Presentations: Send registration information (including: Name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by May 9, 2012. If you need special accommodations due to a disability, please contact Kimberly Franklin (see Contact Person) at least 7 days in advance. Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by May 9, 2012, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses, telephone number, FAX and email of the proposed participants, and an indication of the approximate time requested to make their presentation. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg. Rockville, MD 20857.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' This guidance document describes a means by which norovirus serological reagents may comply with the requirement of special controls for class II devices. This guidance document is to be implemented immediately as the special control for norovirus serological reagents.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Demonstration of a Health Literacy Universal Precautions Toolkit.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.