[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Pages 72424-72425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30286]



National Institutes of Health

Submission for OMB Review; Comment Request Information Program on 
the Genetic Testing Registry

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: Request for comments


SUMMARY: Under the provisions of Section 3507(a) (1)(D) of the 
Paperwork Reduction Act of 1995, the National Institutes of Health 
(NIH) has submitted to the Office of Management and Budget (OMB) a 
request to review and approve the information collection listed below. 
This proposed information collection was previously published in the 
Federal Register on July 27, 2011, (76 FR 44937) and allowed 60 days 
for public comment. Twelve public comments were received. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The National Institutes of Health may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    Proposed Collection: Title: The Genetic Testing Registry; Type of 
Information Collection Request: New collection; Need and Use of 
Information Collection: Laboratory tests for more than 2,000 genetic 
conditions are available; however, there is no centralized public 
resource that provides information about the availability and 
scientific basis of these tests.
    Recognizing the importance of making this information easily 
accessible to health care providers, patients, consumers, and others, 
NIH is developing a voluntary registry of genetic tests. The Genetic 
Testing Registry (GTR) will provide a centralized, online location for 
test developers, manufacturers, and researchers to submit detailed 
information about genetic tests. The overarching goal of the GTR is to 
advance the public health and research in the genetic basis of health 
and disease. As such, the Registry will have several key functions, 
including (1) Encouraging providers of genetic tests to enhance 
transparency by publicly sharing information about the availability and 
utility of their tests; (2) providing an information resource for the 
public, including health care providers, patients, and researchers, to 
locate laboratories that offer particular tests; and (3) facilitating 
genetic and genomic data-sharing for research and new scientific 
    Frequency of Response: The information will be submitted 
voluntarily on a non-repeating, continual basis. Submitters will be 
requested to update their test information at least once every 12 

[[Page 72425]]

    Respondents: Submitters to the GTR are expected to include clinical 
laboratories, researchers, and entities that report and interpret tests 
performed elsewhere. The GTR is not limited to U.S. respondents; it 
will also include submissions from outside the United States. 
Information will be collected and managed using an online submission 
    Estimate of Burden: Although participation in the GTR is voluntary, 
in order to participate, respondents must provide information for a 
certain subset of fields, identified as the ``minimal fields.'' GTR 
includes 31 minimal fields and 85 optional fields. Sixteen of the 31 
minimal fields refer to contact data and other information about the 
laboratory, which the respondent completes only once. These data will 
autopopulate new test records, leaving 15 minimal fields that require 
completion. The GTR will also support bulk submission as an XML file or 
uploading subsets of information from spreadsheets, which will 
significantly reduce the burden for laboratories that want to provide 
information on multiple genetic tests. The annualized cost to 
respondents is estimated at $1,103.

                                            Estimates of Hour Burden
                                       Estimated       number of     Average burden hours     Estimated total
       Type of  respondents            number of     responses per      per  response       annual burden hours
                                      respondents     respondent                                 requested
Laboratory........................             770              12  Minimal Fields: 0.5..  Minimal Fields:
Personnel.........................                                  Optional Fields: 2.5.   4,620.
                                                                                           Optional Fields:
    Total.........................             770  ..............  3.0..................  27,720.

    Request For Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to (202) 395-6974, 
Attention: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instrument, contact: Amy P. Patterson, M.D., Associate Director for 
Science Policy, NIH, by mail to the Office of Biotechnology Activities, 
6705 Rockledge Dr., Suite 750, Bethesda, MD 20892; telephone (301) 496-
9838; fax (301) 496-9839; or email [email protected]; or refer to the GTR 
Web site at http://oba.od.nih.gov/gtr/gtr.html.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: November 16, 2011.
Amy P. Patterson,
Associate Director for Science Policy, NIH.
[FR Doc. 2011-30286 Filed 11-22-11; 8:45 am]