Department of Health and Human Services February 16, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until March 16, 2005, the comment period for the notice that appeared in the Federal Register of August 16, 2004 (69 FR 50386). In the notice, FDA announced a public workshop on scientific and technical considerations related to the development of follow-on protein pharmaceutical products and plans to develop draft guidance and requested comments related to developing and approving follow-on protein pharmaceutical products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) Philadelphia 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, April 13, 2005, from 8:15 a.m. to 5 p.m. and Thursday, April 14, 2005, from 8:15 a.m. to 4 p.m. Location: The public workshop will be held at the Sheraton University City Hotel Philadelphia, 3549 Chestnut St., Philadelphia, PA 19104, 215-387-8000, FAX: 215-387-7920. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 597-2120 ext. 4003, FAX: 215-597-5798, e-mail: mfalcone@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 nonmemebers 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/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 Sheraton University City Hotel at the reduced conference rate, contact the Sheraton University City Hotel (see Location) before March 13, 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 Marie Falcone (see Contact) at least 7 days in advance of the workshop.