[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Page 15013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: The Genetic 
Testing Registry

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 for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on November 25, 2014 (79 FR 70194), and allowed 60-days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment. The Office 
of the Director (OD), 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.
    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: NIH Desk Officer.

DATES: 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments 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.

Proposed Collection: The Genetic Testing Registry, 0925-0651, 
Reinstatment Without Change,--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.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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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: March 13, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-06370 Filed 3-19-15; 8:45 am]
 BILLING CODE 4140-01-P