[Federal Register Volume 63, Number 239 (Monday, December 14, 1998)] [Notices] [Pages 68778-68780] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-33051] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Industry Training on Electronic Records; Electronic Signatures; Video Teleconferences; Public Meeting
Agency
Food and Drug Administration, HHS.
Action
Notice of public meeting.
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The Food and Drug Administration (FDA) (Office of External Affairs, Office of Regulatory Affairs, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health) is announcing the following meeting (video teleconferences) entitled ``Industry Training on 21 CFR Part 11.'' The topics to be discussed are current good manufacturing practice electronic recordkeeping requirements, validation of electronic recordkeeping systems, and the answers to frequently asked questions on part 11 (21 CFR part 11). Date and Time: The meeting will be held on Tuesday, January 12, 1999, 1 p.m. to 4 p.m. Registration information should be faxed to the contact person listed in Table 1 of this document by January 8, 1999.
Contact Person: Laura C. Woolf, Office of Communications, Training and Manufacturers Assistance (HFM-40), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-3840, FAX 301-827-3843, e-mail address ``woolf@cber.fda.gov''.
Supplementary Information
These video teleconferences are intended to inform the FDA regulated industries, and especially, small business about the requirements for electronic recordkeeping according to part 11 and to provide for a dialogue with FDA. These video teleconferences address the requirements of both the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121) that mandates outreach activities by Government agencies directed to small businesses and section 406 (b) of The Food and Drug Administration Modernization Act of 1997 (Pub. L. No. 105-115) that calls for involvement of FDA with its stakeholders in cooperative activities to assure the quality of marketed products. Location: The meeting (video teleconferences) will be held as follows:
Table 1.--Public Meeting (Video Teleconferences) -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Office/Region Meeting Address Time Contact Person -------------------------------------------------------------------------------------------------------------------------------------------------------- Cincinnati District Office 6751 Steger Dr., Cincinnati, OH 45237 1 p.m. to 4 p.m., eastern standard Geraldine H. Cobb (HFR-MA430), Food time (e.s.t.) and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext. 100, FAX 513-679- 2771 New Jersey District Office 10 Waterview Blvd., 3d Fl., 1 p.m. to 4 p.m., e.s.t. Marie T. Falcone (HFR-SW17), Food Parsippany, NJ 07054 and Drug Administration, 900 U.S. Customhouse, 2d & Chestnut Sts., Philadelphia, PA 19106, 215-597- 4391, ext. 4003, FAX 215-597-5798 Chicago District Office 300 South Riverside Plaza, suite 500 12 m. to 3 p.m., central standard Joe T. Petty (HFR-CE1), Food and South, Chicago, IL 60606 time (c.s.t.) Drug Administration, 20 North Michigan Ave., suite 510, Chicago, IL 60602, 312-353-9400, ext. 23, FAX 312-886-1682 Chicago-Central Region 20 North Michigan Ave., suite 510, 12 m. to 3 p.m., c.s.t. Joe T. Petty (HFR-CE1), Food and Chicago, IL 60602 Drug Administration, 20 North Michigan Ave., suite 510, Chicago, IL 60602, 312-353-9400, ext. 23, FAX 312-886-1682 Seattle District Office 22201 23d Dr. SE., Bothell, WA 98021 10 a.m to 1 p.m., Pacific standard Judy R. Keast (HFR-PA13), Food and time (P.s.t.) Drug Administration, 1301 Clay St., suite 1180N, Oakland, CA 94612, 510- 637-3960, ext.12, FAX 510-637-3976
San Francisco District Office 1431 Harbor Bay Pkwy., Alameda, CA 10 a.m. to 1 p.m., P.s.t. Judy R. Keast (HFR-PA13), Food and 94502 Drug Administration, 1301 Clay St., suite 1180N, Oakland, CA 94612, 510- 637-3960, ext.12, FAX 510-637-3976 Los Angeles District Office 19900 MacArthur Blvd., suite 300, 10 a.m. to 1 p.m., P.s.t. Judy R. Keast (HFR-PA13), Food and Irvine, CA 92715 Drug Administration, 1301 Clay St., suite 1180N, Oakland, CA 94612, 510- 637-3960, ext.12, FAX 510-637-3976 Dallas Southwest Regional Office 7920 Elmbrook, suite 102, Dallas, TX 12 m. to 3 p.m., c.s.t. Brenda C. Cox (HFR-SW17), Food and 75247 Drug Administration, 7920 Elmbrook, suite 102, Dallas, TX 75247, 214- 655-8100, ext. 133, FAX 214-655- 8114 Nashville District Office 297 Plus Park Blvd., Nashville, TN 12 m. to 3 p.m., c.s.t. Marie B. Clendening (HFR-SE300), 37217 Food and Drug Administration, 297 Plus Park Blvd., Nashville, TN 37217, 615-781-5392, FAX 615-781- 5383 Atlanta District Office 60 Eighth St. NE., Atlanta, GA 30309 1 p.m. to 4 p.m., e.s.t. Barbara L. Ward-Groves (HFR-SE17), Food and Drug Administration, 60 Eighth St. NE., Atlanta, GA 30309, 404-347-4001, ext. 5256, FAX 404- 347-4349 Atlanta District Raleigh Resident ATCOM, 4920 South Alston Ave., 1 p.m. to 4 p.m., e.s.t. Mary C. Lewis (HFR-SE1525), Food and Post Research Triangle Park, NC 27709 Drug Administration, 310 New Bern Ave., rm. 370, Raleigh, NC 27611, 919-856-4456, FAX 919-856-4776 Denver District Office 6th and Kipling Sts., Bldg. 20, 11 a.m. to 2 p.m., mountain standard Russell W. Gripp (HFR-SW240), Food Denver, CO 80225 time (m.s.t.) and Drug Administration, 6th and Kipling Sts., Bldg. 20, Denver, CO 80225, 303-236-3047, FAX 303-236- 3551 Kansas City District Office 11630 West 80th St., Lenexa, KS 66214 12 m. to 3 p.m., c.s.t Ralph J. Gray (HFR-SW340), Food and Drug Administration, 11630 West 80th St., Lenexa, KS 66214, 913-752- 2105, FAX 913-752-2111 Northeast Regional Office 850 Third Ave., Brooklyn, NY 11232 1 p.m. to 4 p.m., e.s.t. Herman B. Janiger (HFR-NE145), Food and Drug Administration, 850 Third Ave., Brooklyn, NY, 11232, 718-340- 7000, ext. 5043, FAX 718-340-7057 Buffalo District Office 300 Pearl St., suite 100, Buffalo, NY 1 p.m. to 4 p.m., e.s.t Diana D. Monaco (HFR-NE300), Food 14202 and Drug Administration, 300 Pearl St., suite 100, Buffalo, NY 14202, 716-551-4461, ext. 3118, FAX 716- 551-3845 Winchester Engineering and Analytical 109 Holton St., Winchester, MA 01890 1 p.m. to 4 p.m., e.s.t Paula B. Fairfield (HFR-NE245), Food Center and Drug Administration, One Montvale Ave., Stoneham, MA 02180 781-279-1675, ext. 184, FAX 781-279- 1687 --------------------------------------------------------------------------------------------------------------------------------------------------------
Registration: Fax registration information (including name, title, firm name, address, telephone, and fax number) by January 8, 1999, to the contact person listed in Table 1 of this document for the meeting location you wish to attend. There is no charge for attending these meeting. However, space is limited, so you should register early. If you need special accommodations due to a disability, please contact the appropriate contact person at least 7 days in advance.
Dated: December 7, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-33051 Filed 12-11-98; 8:45 am] BILLING CODE 4160-01-F