[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