[Federal Register Volume 62, Number 196 (Thursday, October 9, 1997)]
[Notices]
[Pages 52723-52724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Minimizing Medical Product Errors--A Systems Approach; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Minimizing Medical Product Errors--A Systems 
Approach.'' The purpose of this workshop is to provide a forum for an 
open exchange with industry, health professionals, consumers, and 
others on issues relating to minimizing the potential for medical 
product errors due to similarities in drug names, similar labeling, 
design and packaging of human drugs, biologics, blood/blood products, 
vaccines, and medical devices.

DATES: The public workshop will be held on Thursday, January 8, 1998, 
7:30 a.m. to 6 p.m. An open public hearing to present comments, 4:15 
p.m. to 5:45 p.m. Submit written abstracts by November 7, 1997. Submit 
written notices of participation by December 5, 1997. There is no 
registration fee for this workshop, however, because seating is limited 
interested persons are encouraged to register by December 15, 1997.

ADDRESSES: The public workshop will be held at Natcher Auditorium, 
National Institutes of Health, 45 Center Dr., Bethesda, MD. Submit 
written abstracts and notices of participation to Mary C. Gross 
(address below).

FOR FURTHER INFORMATION CONTACT:
    For general information: Mary C. Gross, Office of External Affairs 
(HF-60), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-03, 
Rockville, MD 20857, 301-827-3440, FAX 301-594-0113, e-mail 
[email protected].
    For information regarding the scientific paper selection process: 
Jerry Phillips, Center for Drug Evaluation and Research, 7500 Standish 
Pl., rm. N271, Rockville, MD 20852, 301-827-5840, FAX 301-594-0183, e-
mail PHILLIPSJ@A1@FDACD.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA will explore the extent of user error occurring with FDA-
regulated products; collect data to help FDA determine what methods, if 
any, already exist to assess the potential for medical product errors; 
hear discussion from outside groups about the appropriate role for FDA 
in minimizing medical product errors; and discuss how the agency can 
effectively collaborate in minimizing user errors.

II. Submission of the Abstracts

    For purposes of discussion at the workshop, FDA is requesting 
abstracts that discuss how best to minimize the incidence of user error 
with FDA-regulated products. FDA will select a limited number of 
abstracts that contain information on what methods, if any, already 
exist to assess the potential for user error in relation to labeling, 
packaging, and design of FDA-regulated products for formal presentation 
at the workshop.
    The abstracts should be printed (typewritten or computer) within 
the confines of an 8 1/2 x 11-inch page of white paper. All lines 
should be single spaced with a three-letter indent for each paragraph. 
The title should be brief and capitalized. The authors name(s) should 
then be listed, underlining each, then list agency, institution, or 
facility involved.

[[Page 52724]]

    The body of the abstract must be organized in the following manner:
    (1) A brief statement of purpose,
    (2) A statement of methods used,
    (3) A statement of results obtained, and
    (4) A statement of conclusions reached.
Each presenter should submit a current curriculum vitae with the 
abstract.
    Interested persons who wish to speak should submit a written notice 
of participation including a name, affiliation, address, phone number, 
and summary of remarks. FDA will allocate the time available for the 
hearing among the persons who properly file notices of their intent to 
make a presentation at the meeting. If time permits, FDA may allow 
additional presentations from interested persons attending the meeting 
who did not submit a written notice of participation to make a 
presentation.

    Dated: October 2, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26707 Filed 10-8-97; 8:45 am]
BILLING CODE 4160-01-F