Notice2021-19384
Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry
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
September 7, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 170 (Tuesday, September 7, 2021)</title>
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[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50140-50141]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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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 54/60 1210
Bulk Submission. Optional Fields.
................ 57 16 29/60 441
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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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