[Federal Register Volume 62, Number 206 (Friday, October 24, 1997)]
[Notices]
[Page 55410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28170]



[[Page 55410]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Grassroots Regulatory Partnership Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) (Office of Regulatory 
Affairs, Nashville District Office and New Orleans District Office), in 
conjunction with the Health Industry Manufacturers Association (HIMA) 
is announcing the following workshop: Grassroots Regulatory Partnership 
Workshop. The topic to be discussed is FDA regulatory requirements for 
the medical device industry. The purpose of the workshop is to promote 
open dialogue between FDA and the medical device industry on quality 
system regulations and medical device reporting requirements.
    Date and Time: The workshop will be held on Tuesday, December 16, 
1997, from 8:30 a.m. to 5 p.m, and on Wednesday, December 17, 1997, 
from 8 a.m. to 3 p.m.
    Location: The meeting will be held at the Holiday Inn Select-
Vanderbilt, 2613 West End Ave., Nashville, TN 37203, 1-800-633-4427.
    Contact: Rebecca K. Keenan, Food and Drug Administration (HFR-SE-
350), Nashville District Office, 297 Plus Park Blvd., Nashville, TN 
37217, 615-781-5380, ext. 145, FAX 615-781-5391.
    Registration: Fax registration information (including name, title, 
firm name, address, telephone, and fax number) to the contact person by 
November 20, 1997. There is no registration fee for this workshop. 
Space is limited, therefore interested parties are encouraged to 
register early.
    If you need special accommodations due to a disability, please 
contact Rebecca K. Keenan at least 7 days in advance.
Supplementary Information: In 1995 President Clinton directed the heads 
of all Federal regulatory agencies to carry out a four step regulatory 
reinvention initiative. The basic idea of the President's initiative 
was to replace adversarial approaches with a partnership approach based 
on clear goals and cooperation. The President specifically directed top 
management from regulatory agencies to hold ``grassroots'' workshops 
with regulated industry, and this workshop is designed to meet that 
requirement.
     Priority will be given to those businesses located in the 
Nashville and New Orleans Districts, which include the States of: 
Alabama, Louisiana, Mississippi, and Tennessee. Companies located 
outside of these States may register to attend the workshop and will be 
accepted if space is available.

    Dated: October 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-28170 Filed 10-23-97; 8:45 am]
BILLING CODE 4160-01-F