[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Pages 11210-11211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04255]
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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
SUMMARY: Under the provisions of 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. This
proposed information collection was previously published in the Federal
Register on November 25, 2014, page 70194 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.
Direct Comments to OMB: 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: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Ms. Sarah Carr, Acting Director, Office of
Clinical Research and Bioethics Policy, 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]. Formal requests for additional plans
and instruments must be requested in writing.
Proposed Collection: The Genetic Testing Registry, 0925-0651,
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 5,000 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 5,536.
[[Page 11211]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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Laboratory Personnel Using Minimal Fields.. 190 29 18/60 1,653
Bulk Submission. Optional Fields. 159 29 14/60 1,076
Laboratory Personnel Not Using Minimal Fields.. 116 29 30/60 1,682
Bulk Submission. Optional Fields. 97 29 24/60 1,125
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Dated: February 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-04255 Filed 2-27-15; 8:45 am]
BILLING CODE 4140-01-P