[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6623-6624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2584]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0066]
Molecular and Clinical Genetics Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 8 and 9, 2011,
from 8 a.m. to 6 p.m.
Addresses: FDA is opening a docket for public comment on this
document. The docket will open for public comment on February 7, 2011,
and will close on March 1, 2011. Interested persons are encouraged to
use the docket to submit either electronic or written comments
regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. 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.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-6313, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory
[[Page 6624]]
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On March 8 and 9, 2011, the committee will discuss and make
recommendations on scientific issues concerning direct to consumer
(DTC) genetic tests that make medical claims. The scientific issues to
be discussed include:
(1) The risks and benefits of making clinical genetic tests
available for direct access by a consumer without the involvement of a
clinician (i.e., without a prescription). The discussion will include
consideration of the benefits and risks of direct access for different
tests or categories of tests that would support differences in the
regulatory approach. Clinical genetic test categories that have been
proposed to be offered directly to consumers include:
(a) Genetic carrier screening for hereditary diseases (e.g., cystic
fibrosis carrier screening);
(b) Genetic tests to predict risk for future development of
disease, in currently healthy persons (e.g., tests to predict risk of
developing breast or ovarian cancer); and
(c) Genetic tests for treatment response prediction (e.g., tests to
predict whether individual will respond to a specific drug).
(2) The risks of and possible mitigations for incorrect,
miscommunicated, or misunderstood test results for clinical genetic
tests that might be beneficial if offered through direct access
testing.
(3) The level and type of scientific evidence appropriate for
supporting direct-to-consumer genetic testing claims including whether
it should be different than that required to support similar claims for
prescription use clinical genetic tests.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 23, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. immediately following lunch on
March 8 and 9. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before February 15, 2011. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by February
16, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, Food and Drug Administration, at 301-796-
5966, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 2, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-2584 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P