2011-2584. Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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.