[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50140-50141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health (NIH), Office of 
the Director (OD) will publish periodic summaries of proposed projects 
to be submitted to the Office of Management and Budget (OMB) for review 
and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Taunton 
Paine, Director, Division of Scientific Data Sharing Policy, Office of 
Science Policy, NIH, 6705 Rockledge Dr., Suite 631, Bethesda, MD 20892, 
or call non-toll free number (301) 496-9838, or Email your request, 
including your address to: <a href="/cdn-cgi/l/email-protection#d98abab0bcb7babc89b6b5b0baa099b4b8b0b5f7b7b0b1f7beb6af"><span class="__cf_email__" data-cfemail="b1e2d2d8d4dfd2d4e1deddd8d2c8f1dcd0d8dd9fdfd8d99fd6dec7">[email protected]</span></a>. Formal requests 
for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address 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.
    Proposed Collection Title: The Genetic Testing Registry, 0925-0651, 
Expiration Date 11/30/21--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 18,000 genetic conditions. The Genetic 
Testing Registry (GTR) provides a centralized, online location for test 
developers, manufacturers, and researchers to

[[Page 50141]]

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. The GTR now also has tests for 
microbes like for SARS-CoV-2 to diagnose COVID-19.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2837.

                                        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
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using      Minimal Fields..              11              16           18/60              53
 Bulk Submission.               Optional Fields.
                                ................             250              16           17/60            1133
Laboratory Personnel Not Using  Minimal Fields..              84              16           54/60            1210
 Bulk Submission.               Optional Fields.
                                ................              57              16           29/60             441
                               ---------------------------------------------------------------------------------
    Total.....................  ................             402            6432  ..............            2837
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    Dated: September 1, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-19384 Filed 9-3-21; 8:45 am]
BILLING CODE 4140-01-P


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