[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