Department of Health and Human Services June 3, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is seeking public comment on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The draft Guidances are now available on the HHS Web site https://aspe.hhs.gov/panflu/antiviral-n-masks.htm

The Surgeon General's Office, in conjunction with the National Institutes of Health, is hosting a conference titled: Surgeon General's Conference on the Prevention of Preterm Birth. The conference is open to the public.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR Meetings in Washington, DC'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Washington, DC. 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 Washington, DC, the week of July 28, 2008, at which the action items from the first ICCR meeting are to be discussed.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on August 12, 2008, from 8 a.m. to 5 p.m., and on August 13, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253- 4970, or email: david.arvelo@fda.hhs.gov. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575- 4221, FAX: 479-575-2165, or email: seideman@uark.edu. Registration: You are encouraged to register by July 29, 2008. The University of Arkansas requires a $150 registration fee to cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop, beginning at 8 a.m. The cost of registration at the site is $200, payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the following form and submit along with a check or money order for $150, payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704.

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 eligibility criteria and the process to be followed by establishments when requesting FDA's approval to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the new inspections by the Accredited Persons Program.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [E-050-2000/0-US- 15] and foreign equivalents. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus.