[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72424-72425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30286]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request Information Program on
the Genetic Testing Registry
AGENCY: National Institutes of Health (NIH), PHS, DHHS.
ACTION: Request for comments
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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 to review and approve the information collection listed below.
This proposed information collection was previously published in the
Federal Register on July 27, 2011, (76 FR 44937) and allowed 60 days
for public comment. Twelve public comments were received. The purpose
of this notice is to allow an additional 30 days for public comment.
The 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.
Proposed Collection: Title: The Genetic Testing Registry; Type of
Information Collection Request: New collection; Need and Use of
Information Collection: Laboratory tests for more than 2,000 genetic
conditions are available; however, there is no centralized public
resource that provides information about the availability and
scientific basis of these tests.
Recognizing the importance of making this information easily
accessible to health care providers, patients, consumers, and others,
NIH is developing a voluntary registry of genetic tests. The Genetic
Testing Registry (GTR) will provide a centralized, online location for
test developers, manufacturers, and researchers to submit detailed
information about genetic tests. The overarching goal of the GTR is to
advance the public health and research in the genetic basis of health
and disease. As such, the Registry will have several key functions,
including (1) Encouraging providers of genetic tests to enhance
transparency by publicly sharing information about the availability and
utility of their tests; (2) providing an information resource for the
public, including health care providers, patients, and researchers, to
locate laboratories that offer particular tests; and (3) facilitating
genetic and genomic data-sharing for research and new scientific
discoveries.
Frequency of Response: The information will be submitted
voluntarily on a non-repeating, continual basis. Submitters will be
requested to update their test information at least once every 12
months.
[[Page 72425]]
Respondents: Submitters to the GTR are expected to include clinical
laboratories, researchers, and entities that report and interpret tests
performed elsewhere. The GTR is not limited to U.S. respondents; it
will also include submissions from outside the United States.
Information will be collected and managed using an online submission
system.
Estimate of Burden: Although participation in the GTR is voluntary,
in order to participate, respondents must provide information for a
certain subset of fields, identified as the ``minimal fields.'' GTR
includes 31 minimal fields and 85 optional fields. Sixteen of the 31
minimal fields refer to contact data and other information about the
laboratory, which the respondent completes only once. These data will
autopopulate new test records, leaving 15 minimal fields that require
completion. The GTR will also support bulk submission as an XML file or
uploading subsets of information from spreadsheets, which will
significantly reduce the burden for laboratories that want to provide
information on multiple genetic tests. The annualized cost to
respondents is estimated at $1,103.
Estimates of Hour Burden
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Estimated
Estimated number of Average burden hours Estimated total
Type of respondents number of responses per per response annual burden hours
respondents respondent requested
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Laboratory........................ 770 12 Minimal Fields: 0.5.. Minimal Fields:
Personnel......................... Optional Fields: 2.5. 4,620.
Optional Fields:
23,100.
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Total......................... 770 .............. 3.0.................. 27,720.
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Request For Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
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: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instrument, contact: Amy P. Patterson, M.D., Associate Director for
Science Policy, NIH, by mail to the Office of Biotechnology Activities,
6705 Rockledge Dr., Suite 750, Bethesda, MD 20892; telephone (301) 496-
9838; fax (301) 496-9839; or email [email protected]; or refer to the GTR
Web site at http://oba.od.nih.gov/gtr/gtr.html.
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.
Dated: November 16, 2011.
Amy P. Patterson,
Associate Director for Science Policy, NIH.
[FR Doc. 2011-30286 Filed 11-22-11; 8:45 am]
BILLING CODE 4140-01-P