[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Page 54900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Training on Electronic Records; Electronic Signatures; 
Satellite Conference; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of satellite conference and public meeting.

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    The Food and Drug Administration (FDA) (Office of Regulatory 
Affairs, Center for Biologics Evaluation and Research, Center for Food 
Safety and Applied Nutrition, Center for Drug Evaluation and Research, 
Center for Devices and Radiological Health, and the Center for 
Veterinary Medicine) is announcing the following satellite conference 
and public meeting entitled ``Industry Training on 21 CFR Part 11.'' 
The topics to be discussed are current good manufacturing practices, 
electronic recordkeeping requirements, validation of electronic 
recordkeeping systems, and the answers to frequently asked questions.
    Date and Time: The satellite conference and public meeting will be 
held on Thursday, October 21, 1999, 1 p.m. to 4 p.m., eastern standard 
time.
    Contact: Laura C. Woolf, Center for Biologics Evaluation and 
Research (HFM-40), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-3840, FAX 301-827-3843, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: The satellite conference announced in this 
document is a repeat of the satellite conference at the public meeting 
announced in the Federal Register of December 14, 1998 (63 FR 68778). 
The satellite conference is intended to inform FDA-regulated 
industries, and especially, small business about the requirements for 
electronic recordkeeping according to 21 CFR part 11 and to provide for 
a dialogue with FDA. The satellite conference addresses the 
requirements of both the Small Business Regulatory Enforcement Fairness 
Act (Public Law 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 (Public Law 
105-115) that calls for involvement of FDA with its stakeholders in 
cooperative activities to ensure the quality of marketed products.
    There are no meeting sites and registration is not necessary for 
the satellite conference and public meeting. To view the satellite 
conference, companies with satellite capability will need to downlink 
the coordinates. The coordinates are as follows: C Band Galaxy 6 @ 99 
west Transponder 20.

    Dated: September 30, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-26222 Filed 10-7-99; 8:45 am]
BILLING CODE 4160-01-F