Notice2021-25670
Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry (Office of the Director)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 24, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 224 (Wednesday, November 24, 2021)</title>
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[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67068-67069]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="/cdn-cgi/l/email-protection#df8cbcb6bab1bcba8fb0b3b6bca69fb2beb6b3f1b1b6b7f1b8b0a9"><span class="__cf_email__" data-cfemail="f3a0909a969d9096a39c9f9a908ab39e929a9fdd9d9a9bdd949c85">[email protected]</span></a>. 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
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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
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