[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