[Federal Register: October 14, 2004 (Volume 69, Number 198)]
[Notices]
[Page 61018-61019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc04-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 2004S-0233]
Stimulating Innovation in Medical Technologies; Public Meeting
AGENCY: Department of Health and Human Services.
ACTION: Notice of public meeting.
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SUMMARY: The Department of Health and Human Services (HHS) is
announcing a public meeting to weigh new ideas and promote new
solutions to encourage innovation in health care and to speed the
development of effective new medical technologies, such as drug and
biological products and medical devices. A high level task force has
been formed within HHS and is charged with issuing a report this year
on appropriate steps that can be taken across HHS to speed the
development and availability of new medical technologies. The purpose
of this public meeting is to obtain input from interested persons on
what steps HHS can take to create or enhance coordination across HHS
agencies in order to stimulate the development of new technologies. HHS
will consider presentations made at the public meeting and comments
submitted to the docket before and after the meeting when developing
the report.
Dates: The public meeting will be held on Monday, November 8, 2004,
from 9:30 a.m. to 4 p.m. Submit electronic requests to speak by October
29, 2004 (see Registration and Request for Presentations). Submit
written or electronic comments by November 15, 2004, to the Division of
Dockets Management (see Addresses).
Location: The public meeting will be held at the Hubert H. Humphrey
Building, rm. 800, 200 Independence Ave. SW., Washington, DC 20201.
Addresses: Submit written comments concerning this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Follow the
instructions for submitting comments.
Contact: Nancy Stanisic, Food and Drug Administration, rm. 9-64,
5600 Fishers Lane, Rockville, MD 20852, 301-827-1660, FAX: 301-443-
9718, e-mail: stanisicn@cder.fda.gov. or Tom Kuchenberg, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Ave. SW., Washington, DC 20201, 202-205-8644.
Registration and Request for Presentations: Send registration
information and requests to speak electronically (including name,
title, firm name, address, telephone, fax number, and presentation
abstract, as well as requests to make oral presentations and
approximate amount of time requested to make the presentation, to Nancy
Stanisic (see Contact) by October 29, 2004. Registration is required to
attend the meeting. Seating is limited to 120 people. If you need
special accommodations due to a disability, please contact Nancy
Stanisic by October 29, 2004.
Transcripts: Transcripts of the meeting may be requested in writing
from the Freedom of Information Office (HFI-35), Food and Drug
[[Page 61019]]
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page. Transcripts of the public meeting will also be available for
review at the Division of Dockets Managment (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION:
I. Background
During the past decade, an increased awareness of medical
technology innovation and its promise and progress has revealed
critical problems in the path from discovery through development to
delivery. This spring, Secretary of Health and Human Services Tommy G.
Thompson appointed a top-level task force to present new ideas on how
HHS can coordinate its efforts to help stimulate medical innovation.
The task force members include: Centers for Disease Control and
Prevention, Director, Julie Gerberding; Centers for Medicare and
Medicaid, Administrator, Mark B. McClellan; Acting Commissioner of Food
and Drugs, Lester M. Crawford; and National Institutes of Health,
Director, Elias A. Zerhouni. Commissioner Crawford will serve as the
task force's Chair.
Secretary Thompson asked the task force to look for opportunities
across HHS to promote speedier access to new innovative medical
technologies that can improve people's health and save lives. He asked
the task force to report to him by the end of the year on ways that
better coordination across HHS could streamline the way we do business
and make safe, effective medical technologies more quickly and readily
available to Americans.
On May 24, 2004, a Federal Register notice (69 FR 29544) was
published asking for comments on how to stimulate innovation in medical
technologies, such as drug and biological products and medical devices.
Comments have been received and are being evaluated and condensed
into material suitable for a report. On November 8, 2004, we will not
only focus on opportunities presented at the public meeting, but those
promising ideas that HHS has already received and plans to highlight.
The ideas will be posted 1 week before the public meeting in the
electronic docket (Docket No. 2004S-0233) located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/04S-0233.htm
.
II. Registration and Presentations
Registration is required to attend the meeting. Seating is limited
to 120 people and will be on a first come, first served basis. If you
need special accommodations due to a disability, please inform Nancy L.
Stanisic by October 29, 2004.
If you wish to present information at the public meeting, submit
your electronic request and an abstract of your presentation by close
of business on October 29, 2004, to Nancy Stanisic (see Contact).
The request to participate should contain the following
information: (1) Presenter's name; (2) address; (3) telephone number;
(4) e-mail address; (5) affiliation, if any; (6) abstract of the
presentation; and (7) approximate amount of time requested for the
presentation.
We request that persons and groups having similar interests
consolidate their comments and present them through a single
representative. We will allocate the time available for the meeting
among the persons who request to present. Because of limited time, we
will accept only one presenter per organization. We reserve the right
to deny requests if the proposed topic is not germane. After reviewing
the requests to present and the abstracts, we will schedule each
appearance and notify each participant by e-mail or telephone of the
time allotted to the person and the approximate time the person's
presentation is scheduled to begin. Presenters planning to use
electronic presentation in Microsoft PowerPoint, Microsoft Word, or
Adobe Acrobat (pdf) must send them to us by close of business on
November 4, 2004. Presenters who do not meet this deadline may provide
handouts of their presentations at the meeting.
After the meeting, the schedule and presentations will be placed on
file in the Division of Dockets Management (see Addresses) under the
docket number listed in the heading of this document.
III. Comments
Interested persons may submit written or electronic comments to the
Division of Dockets Management (see Addresses). You must submit two
copies of comments identified with the docket number found in brackets
in the heading of this document. The received comments may be seen in
the Division of Dockets Management Monday through Friday, between 9
a.m. and 4 p.m.
IV. Transcript
Approximately 30 days after the public meeting, you can examine a
transcript of the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov./ohrms/dockets/default.htm
or at the Division of Dockets Management (see
Addresses) Monday through Friday, between 9 a.m. and 4 p.m. You may
also request a copy of the transcript from the Freedom of Information
Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm.
12A-16, Rockville, MD 20857, at a cost of 10 cents per page or on CD at
a cost of $14.25 each.
Dated: October 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-23064 Filed 10-8-04; 2:23 pm]
BILLING CODE 4160-01-S