[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57804-57805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0486]


Safe Use Initiative; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Safe Use Initiative.'' This public workshop, 
organized and hosted by FDA's Safe Use Initiative Team, will 
communicate the status of ongoing activities and the future vision for 
Safe Use Initiative projects. The workshop will also offer an 
opportunity for the Safe Use Initiative Team to gather input and 
perspectives for future directions and develop collaborative, cross-
sector safe medication use activities with health care stakeholders.

DATES:  The public workshop will be held on November 16, 2010, from 
8:30 a.m. to 4:45 p.m., and November 17, 2010, from 8:30 a.m. to 12 
noon. Suggestions for safe use topics received by October 15, 2010, may 
become the focus for indepth discussions during the workshop breakout 
sessions held the afternoon of November 16, 2010 (see section II of 
this document). Electronic or written comments will be accepted until 
January 31, 2011 (see section IV of this document).

ADDRESSES:  The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993-
0002.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sharon Bakayoko, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 1353, Silver Spring, MD 20993-0002, 301-
796-7600, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The mission of the Safe Use Initiative is to reduce preventable 
harm from FDA-regulated medications. The Safe Use Initiative seeks to 
create and facilitate public and private collaborations aimed at 
reduction of preventable harm.
    FDA announced the ``FDA's Safe Use Initiative--Collaborating to 
Reduce Preventable Harm From Medications'' (the Safe Use Report) on 
November 5, 2009 (74 FR 57319). The Safe Use Report calls for an open 
and transparent process with health care stakeholders to identify 
candidate drug/drug classes or therapeutic areas that could benefit 
from a collaborative approach to harm reduction.
    The first steps in public engagement involved outreach to the 
health care community--through public meetings, teleconferences, and 
listening sessions with stakeholder groups (e.g., health care 
professionals, consumer groups, insurers, and industry). The goals were 
to inform organizations about the Safe Use Initiative, to obtain 
feedback about medication safety and preventable medication harm, and 
to seek opportunities for collaboration. The suggestions that emerged 
from the safe use outreach activities ranged from preventing a specific 
drug-related adverse event to broad and overarching themes in health 
care.

II. Scope of the Public Workshop

    This public workshop expands the Safe Use Initiative outreach 
efforts. It will provide a forum to engage the health care community 
about collaborations, interventions, and metrics for ongoing and future 
projects to make medications safer.
    We are soliciting input in advance of the public workshop about 
topics for potential safe use collaborations. FDA will consider all 
topics. However, if submitted by October 15, 2010, some topics may 
become the focus for more indepth discussions and partnership 
development during the public workshop. Please submit topic suggestions 
(identified with the docket number found in brackets in the heading of 
this document) to the Division of Dockets Management (see ADDRESSES). 
When submitting a topic for consideration, please suggest how it could 
become a safe use project, e.g., other health care partners who might 
have an interest in the issue, kinds of interventions to reduce 
preventable harm, metrics, etc.

III. Attendance and Registration to Speak

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures. There is no fee to attend the 
workshop, and attendees who do not wish to make an

[[Page 57805]]

oral presentation do not need to register. Seating is limited and will 
be on a first-come, first-served basis.
    If you would like to make an oral presentation during the public 
session on November 17, 2010, you must register and provide an abstract 
of your presentation by the close of business on October 15, 2010. To 
speak, submit your name, title, business or organization affiliation 
(if applicable), address, telephone number, fax number, and email 
address to Sharon Bakayoko (see FOR FURTHER INFORMATION CONTACT). FDA 
has included areas of interest in section II of this document. Please 
indicate the topic area you wish to address in your presentation. FDA 
will do its best to accommodate requests to speak. Individuals and 
organizations with common interest are urged to consolidate or 
coordinate their presentations and to request time for a joint 
presentation. FDA will determine the amount of time allotted to each 
presenter and the approximate time that each oral presentation is 
scheduled to begin. Persons registered to make an oral presentation 
should check in at the registration desk before the workshop. Time will 
be allowed during the scheduled agenda for attendees to ask questions 
of panelists. In addition, we strongly encourage electronic or written 
comments to the docket (see section IV of this document).
    If you need special accommodations because of a disability, please 
contact Sharon Bakayoko at least 7 days before the workshop.

IV. Comments

    Regardless of attendance at the workshop, interested persons may 
submit to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments regarding this document, including 
suggestions for workshop topics. It is only necessary to send one set 
of comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Information about the Safe Use Initiative, including the Safe Use 
Report, is available on the Internet at http://www.fda.gov/safeuseinitiative. Information about the workshop will be posted on 
this Web site when it is available.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.fda.gov/safeuseinitiative and http://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD. A transcript will also be available in either 
hardcopy or on CD-ROM, after submission of a Freedom of Information 
request. Written requests are to be sent to the Division of Freedom of 
Information (HFI-35), Office of Management Programs, Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23641 Filed 9-21-10; 8:45 am]
BILLING CODE 4160-01-S