[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Pages 62406-62407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25411]



National Institutes of Health

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

AGENCY: National Institutes of Health, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: 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 
    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: http://www.dcconvention.com/.
    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 http://oba.od.nih.gov/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 [email protected]; 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 [email protected] 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 [email protected] or 301-496-9838.


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

[[Page 62407]]

Registry (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 http://oba.od.nih.gov/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 http://oba.od.nih.gov/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 
    5. What mechanisms can be used to provide materials that explain 
the GTR's data elements to audiences with varying technical expertise?

    Dated: October 5, 2010.
Amy P. Patterson,
Acting Associate Director for Science Policy, NIH.
[FR Doc. 2010-25411 Filed 10-7-10; 8:45 am]