[Federal Register: December 22, 2005 (Volume 70, Number 245)]
[Notices]
[Page 76060-76061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de05-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0329]
Hand-Held, Doppler Ultrasound Prenatal Listening Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
workshop to discuss scientific information bearing on whether hand-held
Doppler ultrasound prenatal listening devices should be made available
for use over-the-counter (OTC). This 1-day workshop is intended to
provide members of the academic, scientific, and clinical communities;
industry; consumer, and patient advocacy groups; and others with a
forum for presenting their perspectives about available scientific
literature and clinical studies relating to hand-held Doppler
ultrasound prenatal listening devices. Written comments submitted to
the docket before the workshop and information gathered at the workshop
will be used by FDA to further identify and evaluate the risks and
benefits associated with possible OTC availability of hand-held
prenatal Doppler ultrasound listening devices.
Date and Time: The public workshop will be held on Wednesday, March
29, 2006, from 9 a.m. to 3:30 p.m. The deadline for registration is
Friday, March 10, 2006. Requests to make presentations at the public
workshop and written or electronic comments will be accepted until
Friday, March 10, 2006.
Addresses: The public workshop will be held at the Hilton
Washington DC North, 620 Perry Pkwy., Gaithersburg, MD, 20877.
Additional information about and directions to the facility are
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hilton.com/en/hi/hotels/index.jhtml?ctyhocn=GAIGHHF.
(FDA has verified the Web site address,
but FDA is not responsible for any subsequent changes to the Web site
after this document publishes in the Federal Register.) Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
[[Page 76061]]
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.
Contact: Domini Cassis, Center for Devices and Radiological Health
(HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850, e-mail: domini.cassis@fda.hhs.gov, 240-276-2342.
Agenda: At the workshop, FDA will hear presentations and oral
comments from interested members of the public regarding Doppler
ultrasound technology as used in hand-held prenatal listening devices.
FDA anticipates that presenters may include representatives from the
academic, scientific, and clinical communities; device, drug, and
biological product manufacturers; consumer and patient advocacy groups;
and others.
Registration and Requests for Presentations: There is no fee to
attend this public workshop; however, registration is required. The
deadline for registration is Friday, March 10, 2006. Early registration
is recommended, as seats are limited. Space will be filled in order of
receipt of registration. There will be no on-site registration. Please
submit registration information (including name, title, firm name,
address, e-mail address, telephone number, and fax number) by March 10,
2006 (see Contact). Interested persons who are unable to attend the
workshop are encouraged to submit written comments (see Request for
Comments).
Those who wish to make presentations during the public workshop
should submit written notification including the following: (1) The
specific issue(s) you intend to address; (2) the names and addresses of
all individuals that will participate in your presentation; (3) the
approximate amount of time your presentation will require; and (4) two
copies of all presentation materials to Domini Cassis by March 10,
2006. Presentations will be limited to the topics outlined in the
SUPPLEMENTARY INFORMATION section of this document and, depending on
the number of speakers, FDA may limit the time allotted for each
presentation. If you need special accommodations due to a disability,
please contact Anne Marie Williams at 301-594-1283 at least 7 days in
advance of the workshop.
Request for Comments: Interested persons may submit to the Division
of Dockets Management (see Addresses) written or electronic comments
regarding this document. Two paper copies of any mailed comments are to
be submitted, except that individuals may submit one paper copy.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen at the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Transcripts: Following the workshop, transcripts will be available
for review at the Division of Dockets Management (see Addresses).
SUPPLEMENTARY INFORMATION:
I. Background
Since July 2002, FDA has received three citizen petitions
requesting that it grant OTC status to hand-held prenatal listening
devices that produce no more than 20 mW/cm2 of Doppler ultrasound
intensity (FDA Docket Nos. 2002P-0338, 2003P-0438, and 2004P-0329.)
Currently, these products are class II devices that are legally
available only by prescription. FDA denied petitions 2002P-0338 and
2003P-0438, citing its concern over the safety of exposing a developing
fetus to Doppler ultrasound without the order or instruction of a
physician, and referencing the following studies:
1. ``Sinistrality--A Side-Effect of Prenatal Sonography: A
Comparative Study of Young Men.'' Keiler, H., et al.; Epidemiology;
12:618-623 (2001).
2. ``Acceleration of Fresh Fracture Repair Using the Sonic
Accelerated Fracture Healing System (SAFHS): A Review.'' Warden, S.J.,
et al.; Calcified Tissue International; 66:157-163 (2000).
3. ``Acceleration of Tibial Fracture-Healing by Non-Invasive, Low
Intensity Pulsed Ultrasound.'' Heckman, J., et al.; Journal of Bone and
Joint Surgery; 76A:26-34 (1994).
4. ``Accelerated Healing of Distal Radial Fractures With the Use of
Specific, Low-Intensity Ultrasound. A Multicenter, Prospective,
Randomized, Double-Blind, Placebo-Controlled Study.'' Kristiansen, T.,
et al.; Journal of Bone and Joint Surgery, 79A:961-973 (1997).
5. ``Routine Ultrasound Screening in Pregnancy and the Children's
Subsequent Handedness.'' Kieler, H., et al.; Early Human Development;
50:233-245 (1998).
FDA reiterated its concerns in response to the most recent
petition, 2004P-0329, but agreed to hold a public workshop in which
relevant issues surrounding the proposal for OTC sales, distribution,
and unsupervised use of these devices could be discussed. This public
workshop is not intended to address legal or regulatory issues. Rather,
FDA intends to collect information from outside experts and
stakeholders that could help the agency better identify and evaluate
the risks and benefits of uncontrolled exposure to Doppler ultrasound
energy introduced through hand-held prenatal listening devices.
II. References
The above references have been placed on display in the Division of
Dockets Management (see Addresses) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7643 Filed 12-21-05; 8:45 am]
BILLING CODE 4160-01-S