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Plan To Develop a Genetic Testing Registry at the National Institutes of Health; Public Meeting; Request for Comments

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National Institutes of Health, HHS.


Notice of public meeting; request for comments.


The National Institutes of Health is announcing a public meeting to gather stakeholder perspectives on its plan to develop the Genetic Testing Registry. The meeting will provide a forum for interested stakeholders to provide comments on specific aspects of the plan.

Date and Time: The public meeting will be held November 2, 2010, from 9 a.m. to 12 p.m.

Location: The public meeting will be held at the Walter E. Johnson Convention Center, Room 147, 801 Mount Vernon Place, NW., Washington, DC 20001. For directions, please contact the Convention Center at 202-249-3000 or refer to the following Web site:​.

Special accommodations: Anyone planning to attend the meeting who needs special assistance, such as sign language interpretation or other reasonable accommodations, is asked to contact Cathy Fomous (see Contacts section) by October 26, 2010.

Registration: If you wish to attend the public meeting, please register by October 27, 2010. Registration is free and on a first-come, first-served basis. Pre-registration can be completed online at​gtr/​gtr_​meetings.html. Persons without Internet access may call Ms. Nicole Numbers at 301-650-8660. Onsite registration will be based on space availability.

Requests for Oral Presentations: Interested persons who would like to make oral comments during the meeting will be given 5 minutes to do so if they submit their request by October 27, 2010, to Cathy Fomous. Send requests by e-mail to; by fax to 301-496-9839; or via postal service to Cathy Fomous, Ph.D., Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892. The request should include the commenter's name, title, affiliation, address, e-mail address, and telephone number. All requests should indicate which questions outlined below in the section on Public Meeting Focus will be addressed. Depending on the number of individuals and organizations that submit requests to make oral remarks, the allotted time may be expanded or shortened to provide all interested parties an opportunity to present.

Written Comments: Interested persons who cannot attend the meeting may submit written comments on the questions outlined below. Comments should be submitted to Cathy Fomous via e-mail, fax, or postal service using the above contact information. The comment period for written comments closes on November 12, 2010.

Contacts: For questions about the meeting logistics, please contact Ms. Nicole Numbers at or 301-650-8660. For special accommodations or questions about the meeting agenda and public comments, please contact Cathy Fomous, Ph.D., NIH Office of Biotechnology Activities at or 301-496-9838.

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I. Background

Advances in the knowledge of genetic factors involved in health and disease have been accompanied by a rapid rise in the availability of genetic tests, including those tests that diagnose or assess the risk for disease, provide prognostic information, and guide the selection of drug therapies and dosing. Although more than 2,000 genetic tests are available, there is no public resource that provides centralized information about the availability and scientific basis of these tests.

On March 18, 2010, the National Institutes of Health (NIH) announced its intent to develop the Genetic Testing Start Printed Page 62407Registry (GTR) to provide access to information that enables informed decision making by patients, caregivers, health care professionals, clinical laboratory professionals, payers, and policy makers. The goals of the GTR are to promote transparency by encouraging test providers to share information about the purpose and validity of their tests; provide a resource for the public—including health care providers, patients, and researchers—to locate laboratories that offer particular tests; and facilitate genomic data sharing for research and new scientific discoveries.

The GTR project is overseen by the NIH Office of the Director. The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, is responsible for developing the registry, which is expected to be available in 2011.

As part of the development process, the NIH issued a Request for Information (RFI) on July 12, 2010, to seek input from the public on its plan for this project. The RFI comment period ended August 2, 2010. NIH received 68 comments in response to the RFI, and these comments are available at​gtr/​gtr_​comments.html.

II. Public Meeting Focus

NIH will begin the November 2 public meeting with an overview of the public comments that were received in response to the RFI and a presentation of prototype data elements for the GTR. The remainder of the meeting will be dedicated to a moderated discussion of responses to specific questions about the GTR. The meeting agenda will be available on the Internet at​gtr/​gtr_​meetings.html.

The RFI comments have been helpful in the development of a prototype of registry data elements. However, NIH seeks further public input on specific aspects of the GTR and requests that comments address the questions below. If time permits, discussion of additional issues will be accommodated.

1. Based on an analysis of RFI comments and other operational issues, NIH is considering a phased approach to developing the GTR in which some types of tests would be eligible for early entry in the GTR and other types of tests would be added later. If NIH adopts this approach, what criteria should be used to determine which genetic tests should be included in the first phase of the GTR, and what types of tests would meet these criteria?

2. Several RFI responders, who are potential data submitters, noted that it makes more sense for clinicians and genetics professionals to be the source of clinical utility evidence rather than test developers and/or test providers. Given that data submitters are unlikely to have clinical utility information, how is this data element best addressed in the GTR?

3. Among responders to the RFI question about including a data element for test cost, half were in favor of including cost information and half were opposed. What are the benefits, risks, and challenges of including cost information in the GTR?

4. What safeguards can be put in place to prevent GTR users from misunderstanding, misinterpreting, or misusing the information in the Registry?

5. What mechanisms can be used to provide materials that explain the GTR's data elements to audiences with varying technical expertise?

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Dated: October 5, 2010.

Amy P. Patterson,

Acting Associate Director for Science Policy, NIH.

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[FR Doc. 2010-25411 Filed 10-7-10; 8:45 am]