[Federal Register Volume 63, Number 15 (Friday, January 23, 1998)]
[Rules and Regulations]
[Page 3465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. 90N-0172]
RIN 0910-AA09


Quality System Design Control; Open Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following meeting: Quality System Design Control open public meeting. 
The topic to be discussed is the midcourse review of the new design 
control requirements. This action is being taken in accordance with the 
current good manufacturing (CGMP) final rule that appeared in the 
Federal Register of October 7, 1996.

DATES: The meeting will be held on, February 2, 1998, from 8:30 a.m. to 
4:30 p.m. Written requests for oral presentations by January 28, 1998.

ADDRESSES: The meeting will be held at the National Institutes of 
Health (NIH), Natcher Auditorium, 45 Center Dr., Bldg. 45, Bethesda, 
MD. Contact for any changes: (1) Via Internet at http://www.fda.gov/
cdrh/gmp, or (2) telephone toll-free at 1-800-638-2041.

FOR FURTHER INFORMATION CONTACT: 
    For information regarding registration: Mary Ann Fitzgerald, or
    For information regarding the meeting or requests for oral 
presentations: Kimberly A. Trautman, Center for Devices and 
Radiological Health (HFZ-341), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4648, FAX 301-594-4672.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 7, 1996 
(61 FR 52602), FDA stated that it would hold an open public meeting in 
early 1998 to discuss, and to further explore any concerns industry 
might be having in implementing the new design control requirements. 
Specifically, the results of the first several months of design control 
inspections will be reviewed and any adjustments to the designated 
inspectional strategy of guidances will be addressed. Also, FDA will 
evaluate the information gathered at this point and determine if design 
control requirements, as written in the final rule, are appropriate to 
obtain the goals expressed in the preamble. Particular attention will 
be paid to clarity of information obtained, the appropriateness of the 
information collected with respect to the design control requirements, 
the manner in which the investigators are writing their observations, 
and any requirements that seem to be giving manufacturers a problem or 
where there might be misunderstandings as to what the regulation 
requires. It is important to note that only the requirements and issues 
surrounding design controls codified will be addressed.
    Fax written requests for oral presentations, (including name, 
title, firm name, address, telephone, and fax number), and an outline 
of your presentation to the contact person listed above by January 28, 
1998. No telephone requests will be accepted. You will be notified by 
facsimile whether or not the speaker's list is full. If you cannot be 
reached by facsimile, please note that in your request.
    If you need special accommodations due to a disability, please 
contact Georgette Smith, NIH Conference Center, 301-496-9966, at least 
7 days in advance.

    Dated: January 20, 1998.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 98-1822 Filed 1-21-98; 3:22 pm]
BILLING CODE 4160-01-F