[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67068-67069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25670]


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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 (Office of the Director)

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 recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open

[[Page 67069]]

for Public Comments'' or by using the search function.

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: [email protected]. Formal requests 
for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on September 7, 2021, page 
50140 (86 FR 50140) 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 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 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 2,299.

                                        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      Minimal Fields..              11              16           18/60              53
 Bulk Submission.
                                Optional Fields.             250              16           17/60            1133
Laboratory Personnel Not Using  Minimal Fields..              84              16           30/60             672
 Bulk Submission.
                                Optional Fields.              57              16           29/60             441
                                                 ---------------------------------------------------------------
    Total.....................                               402            6432  ..............           2,299
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    Dated: November 18, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-25670 Filed 11-23-21; 8:45 am]
BILLING CODE 4140-01-P