[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Pages 44937-44938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18970]



National Institutes of Health

Request for Comments Under the Paperwork Reduction Act, Section 

SUMMARY: The National Institute of Health (NIH), as part of its 
continuing effort to reduce paperwork and respondent burden, invites 
the general public and other Federal agencies to take this opportunity 
to comment on proposed and/or continuing information collections, as 
required by the Paperwork Reduction Act of 1995, Section 3506.
    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, which means submitters 
will register a test once and can add new tests on a continual basis. 
Submitters will be requested to update their test information at least 
once every 12 months.
    Description of Respondents: Submitters to the GTR are expected to 
include clinical laboratories, test manufacturers, 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: Data from the GeneTests Laboratory Directory, 
which is currently the most comprehensive listing available for 
laboratories that provide genetic tests, was used to estimate both the 
number of participating laboratories as well as the number of genetic 
tests which might be submitted to the GTR. Analysis of the database 
showed that there are 593 laboratories and approximately 7,800 genetic 
tests listed in GeneTests. Approximately half of the laboratories in 
GeneTests (291, or 49 percent) list 12 or fewer tests, while 
approximately 40 percent (239) list between 13 and 100 tests, and the 
remaining 10 percent (63) list 100 or more tests. To account for 
genetic test providers that are not listed in GeneTests, the number of 
laboratories was multiplied by 1.2, bringing the estimated number of 
potential participants in GTR to 770. A multiplier of 1.2 was used to 
account for tests that are not in GeneTests but that might be submitted 
to the GTR, including test categories not covered by GeneTests (e.g., 
pharmacogenomic tests), as well as tests that meet the criteria for 
GeneTests but that have not been submitted to the database. Applying 
the 1.2 multiplier yields an estimated 9,360 tests for which 
information could be submitted to GTR.
    Although participation in the GTR is voluntary, in order to 
participate, the submitter must provide information for a certain 
subset of data fields, identified as the ``minimal fields.'' GTR 
includes 31 minimal fields and 85 optional fields. Separate estimates 
of hour burden are provided for minimal, optional, and all fields 
(Table 1). The calculations include the time and effort necessary for 
the test provider to gather information for the data elements and to 
enter the information into the GTR online submission form.
    Based on simulated trials of entering test information into GTR, it 
will take submitters an average of 0.5 hours per test to provide 
information for the minimal fields. With an average of 12.2 tests per 
respondent, the estimated annual hour burden for a respondent to 
complete the minimal fields is 6.1 hours. An estimated additional 2.5 
hours per test was projected for the optional fields for an annual 
burden of 30.5 hours per respondent. The annual hour burden for a 
respondent to complete all fields is 36.6 hours.
    The calculations for annual burden reflect the average time for 
submitters who are familiar with their tests and know where to find 
information about the tests. For those submitters who are not familiar 
with information about their tests, it may take longer than the 
estimated 2.5 hours to provide the optional fields information. 
However, submitters should become more efficient in data entry as they 
gain experience with GTR, and significant time savings can be achieved 
by laboratories with large numbers of tests who use the bulk upload 
feature. In addition, those test providers whose

[[Page 44938]]

tests are already listed in GeneTests will have the data from GeneTests 
automatically transferred to GTR, saving them data entry time.

                                        Table 1--Estimates of Hour Burden
                                                                    Estimated       Annual hour
     Type of respondent          Number of      Frequency of    average time per    burden per     Total annual
                                respondents       response          response        respondent      hour burden
Laboratory Personnel........             770  An average of     Minimal Fields:              6.1           4,697
                                               12.2 tests per    0.5 hr.
                                               submitted once.
                                                                Optional Fields:            30.5          23,485
                                                                 2.5 hr.
                                                                Total (All                  36.6          28,182
                                                                 Fields): 3.0 hr.

    To estimate the annualized cost to respondents, NIH used the mean 
hourly wage of medical and clinical laboratory technicians from the 
U.S. Bureau of Labor and Statistics 2010 National Occupational 
Employment and Wage Estimates.\1\ Based on an average of 12.2 
submissions per respondent, 3.0 hours to provide information for all 
data fields (i.e., minimal and optional fields) per submission, and a 
mean hourly wage of $22.85, the estimated annualized cost to 
respondents is $836.30. Cost savings can be achieved by laboratories 
with large numbers of tests that use the bulk upload feature. Table 2 
provides the estimated annualized cost per respondent and for all 

    \1\ U.S. Bureau of Labor and Statistics. May 2010 National 
Occupational Employment and Wage Estimates. See http://www.bls.gov/oes/current/oes_nat.htm#29-0000. Accessed June 8, 2011.

                                Table 2--Estimated Annualized Cost to Respondents
                                                                                                   Total annual
                                   Average                                                         cost  (based
                                  number of    Estimated average                     Estimated     on a total of
      Type of respondent         submissions    time (hours) per    Mean hourly     annual cost        9,360
                                     per         submission per        wage             per         submissions
                                 respondent        respondent                       respondent        for 770
Laboratory Personnel.........            12.2  Minimal Fields:            $22.85         $139.38       $106, 938
                                               Optional Fields:            22.85          696.92        534, 690
                                            ;  All Fields: 3.0..           22.85          836.30        641, 628

    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.

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. Comments should be directed to Amy Patterson, M.D. 
through the contact information below.

FOR FURTHER INFORMATION CONTACT: For additional information on the 
proposed project, please visit the GTR Web site (http://oba.od.nih.gov/gtr/gtr.html) or 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 e-mail [email protected], 
Attention: Dr. Patterson.

    Dated: July 21, 2011.
Amy P. Patterson,
Associate Director for Science Policy, NIH.
[FR Doc. 2011-18970 Filed 7-26-11; 8:45 am]