[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70194-70195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The Genetic Testing 
Registry

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the Office of the Director (OD), 
National Institutes of Health (NIH), will publish periodic summaries of 
proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
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) 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) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to 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.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Ms. Sarah 
Carr, Acting Director, Office of Clinical Research and Bioethics 
Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, 
Bethesda, MD 20892, or call non-toll-free number (301) 496-9838, or 
Email your request, including your address to: [email protected]. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: The Genetic Testing Registry, 0925-0651, 
Expiration Date 02/28/2015--EXTENSION, Office of the Director (OD), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: Clinical laboratory tests 
are available for more than 5,000 genetic conditions. The Genetic 
Testing Registry (GTR) provides a centralized, online location for test 
developers, manufacturers, and researchers to voluntarily submit 
detailed information about the availability and scientific basis of 
their genetic tests. The GTR is of value to clinicians by providing 
information about the accuracy, validity, and usefulness of genetic 
tests. The GTR also highlights evidence gaps where additional research 
is needed.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 5,536.

[[Page 70195]]



                                        Estimated Annualized Burden Hours
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                                                     Estimated       Number of    Average burden
      Type of respondent            Form name      annual number   responses per   per response    Total annual
                                                  of respondents    respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using      Minimal Fields..             190              29           18/60           1,653
 Bulk Submission.
                                Optional Fields.             159              29           14/60           1,076
Laboratory Personnel Not Using  Minimal Fields..             116              29           30/60           1,682
 Bulk Submission.
                                Optional Fields.              97              29           24/60           1,125
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    Dated: November 17, 2014.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2014-27898 Filed 11-24-14; 8:45 am]
BILLING CODE 4140-01-P