[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]
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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 ``[email protected]''.
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)
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FDA Office/Region Meeting Address Time Contact Person
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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
[[Page 68779]]
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
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[[Page 68780]]
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