[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]

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