Department of Health and Human Services September 21, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.

The Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, February 8, 2006, from 8:15 a.m. to 5 p.m. and Thursday, February 9, 2006, from 8:15 a.m. to 4 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel Houston Medical Center, 6701 South Main, Houston, TX 77030, 713- 797-1110, FAX: 713-796-8291. Contact: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: oraswrsbr@ora.fda.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $485 (member), $560 (nonmember), or $460 (government employee nonmember). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to https://www.socra.org/html/FDA Conference.htm (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-345-7369, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Crowne Plaza Hotel Houston Medical Center at the reduced conference rate, contact the Crowne Plaza Hotel Houston Medical Center (see Location) before January 17, 2005. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact David Arvelo (see Contact) at least 7 days in advance of the workshop.

Notice is hereby given that a noncompetitive single source program expansion supplement to an ongoing competitive award is being made to the United States Conference of Catholic Bishops (USCCB) in response to an unsolicited application. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2006. USCCB's application is expected to address issues critical to the development and implementation of marriage education programs for refugees by opening three new program sites. In September of 2003, ORR awarded USCCB a grant of $1,000,000,000 to develop a Refugee Family Enrichment program which included technical assistance to subgrantees. Over the past two years, USCCB has established an effective program in sites that have successfully prepared thousands of refugee families for the challenges they will face during resettlement. Because other Refugee Marriage Enrichment grantees are primarily regional in scope, we believe USCCB is uniquely suited to effectively implement this supplemental award. USCCB has affiliates across the country and has no physical or programmatic limitations regarding which ethnic groups they can serve. We believe that by allowing them to increase the number of sites, that it would be a cost-effective way of helping more refugees develop the skills that help their marriages succeed and give their children a better chance of success in the U.S. Without it, these sites might struggle to provide refugee clients with the programs they need in order to achieve self-sufficiency. The proposed project period is 9/30/2005-9/29/2006. Assistance to support grantees in developing better approaches to the delivery of services provided to refugees is authorized by section 412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C. 1522(c)(1)).

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710a, to achieve expeditious commercialization of results of federally funded research and development. A U.S. non- provisional patent application and a PCT application have been filed. National stage foreign patent applications claiming priority to the PCT application are expected to be filed within the appropriate deadlines to extend market coverage for U.S. companies and may also be available for licensing.