83 FR 31410 - Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 129 (July 5, 2018)

In compliance with 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.

[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31410-31411]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14435]


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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

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with 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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of

[[Page 31411]]

the data collection plans and instruments, contact: Dr. Dina Paltoo, 
Director, Scientific Data Sharing Policy Division, 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].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 2, 2018, page 
14018 (83 FR 14018) 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.
    In compliance with 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.
    Proposed Collection: The Genetic Testing Registry, 0925-0651, 
Expiration Date 07/31/2018--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 10,000 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 4,198.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of     Average time
               Type of respondent                               Form name                    Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)      burden hour
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Laboratory Personnel Using Bulk Submission.....  Minimal Fields.........................             313              25           18/60           2,348
Optional Fields................................
                                                 .......................................             313              25            6/60             783
Laboratory Personnel Not Using Bulk Submission.  Minimal Fields.........................              64              25           30/60             800
Optional Fields................................
                                                 .......................................              64              25           10/60             267
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             377          18,850  ..............           4,198
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    Dated: June 28, 2018.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2018-14435 Filed 7-3-18; 8:45 am]
 BILLING CODE 4140-01-P