Request for Comments Under the Paperwork Reduction Act, Section 3506, 44937-44938 [2011-18970]
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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
and Other Variations in Organ Distribution
and the Alignment of the Centers for
Medicare and Medicaid Services’ Regulatory
Requirements with the Organ Procurement
and Transplantation Network and the Health
Resources and Services Administration.
ACOT presentations will include an update
on the Kidney Allocation Policy; financial
challenges of kidney paired donation;
circulatory determination of death criteria;
organ donation and transplantation alliance;
vascularized composite allografts; and
disease transmission and informed consent.
Agenda items are subject to change as
priorities indicate.
After the presentations and Committee
discussions, members of the public will have
an opportunity to provide comments.
Because of the Committee’s full agenda and
the timeframe in which to cover the agenda
topics, public comment will be limited. All
public comments will be included in the
record of the ACOT meeting. Meeting
summary notes will be made available on the
Department’s donation Web site at https://
www.organdonor.gov/legislation.asp. The
draft meeting agenda will be available on the
Department’s donation Web site at https://
www.organdonor.gov/legislation.asp and at
https://www.team-psa.com/dot/spring2011/
ACOT.
Registration can be completed by e-mailing
or faxing a confirmation of participation to
Brittany Carey, with the HRM/Professional
and Scientific Associates (PSA), the logistical
support contractor for the meeting. Ms.
Carey’s e-mail address is b_carey@teampsa.com and her fax number is (703) 234–
1701. Individuals without access to the
Internet who wish to register may call
Brittany Carey with HRM/PSA at (703) 889–
9033.
For Further Information Contact: Patricia
Stroup, Executive Secretary, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland 20857;
telephone (301) 443–1127.
Dated: July 21, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–18935 Filed 7–26–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sroberts on DSK5SPTVN1PROD with NOTICES
Request for Comments Under the
Paperwork Reduction Act, Section
3506
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
SUMMARY:
VerDate Mar<15>2010
17:08 Jul 26, 2011
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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
PO 00000
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Sfmt 4703
44937
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
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44938
Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
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
Number of
respondents
Type of respondent
Laboratory Personnel ....................
770
Frequency of response
Annual hour
burden per
respondent
Total annual
hour burden
Minimal Fields: 0.5 hr .......
6.1
4,697
Optional Fields: 2.5 hr ......
30.5
23,485
Total (All 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
An average of 12.2 tests
per respondent; submitted once.
Estimated average time
per response
36.6
28,182
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 respondents.
TABLE 2—ESTIMATED ANNUALIZED COST TO RESPONDENTS
Average
number of
submissions
per
respondent
Type of respondent
12.2
Mean hourly
wage
Total annual
cost
(based on a
total of 9,360
submissions
for 770
respondents)
$22.85
$139.38
$106, 938
22.85
696.92
534, 690
All Fields: 3.0 .............................
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.
Minimal Fields: 0.5 .....................
Optional Fields: 2.5 ....................
sroberts on DSK5SPTVN1PROD with NOTICES
Laboratory Personnel ..............................
Estimated average time (hours)
per submission per respondent
Estimated
annual cost
per
respondent
22.85
836.30
641, 628
publication. Comments should be
directed to Amy Patterson, M.D. through
the contact information below.
For
additional information on the proposed
project, please visit the GTR Web site
(https://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
gtr@od.nih.gov, Attention: Dr. Patterson.
FOR FURTHER INFORMATION CONTACT:
Dated: July 21, 2011.
Amy P. Patterson,
Associate Director for Science Policy, NIH.
[FR Doc. 2011–18970 Filed 7–26–11; 8:45 am]
BILLING CODE 4140–01–P
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
DATES:
1 U.S. Bureau of Labor and Statistics. May 2010
National Occupational Employment and Wage
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18:39 Jul 26, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery:
National Cancer Center (NCI)
30-Day notice of submission of
information collection approval from
the Office of Management and Budget
and request for comments.
ACTION:
As part of a Federal
Government-wide effort to streamline
the process to seek feedback from the
public on service delivery, National
Cancer Center (NCI) has submitted a
Generic Information Collection Request
(Generic ICR): ‘‘Generic Clearance for
the Collection of Qualitative Feedback
on Agency Service Delivery’’ to OMB for
approval under the Paperwork
SUMMARY:
Estimates. See https://www.bls.gov/oes/current/
oes_nat.htm#29-0000. Accessed June 8, 2011.
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]]>Agencies
[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44937-44938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comments Under the Paperwork Reduction Act, Section
3506
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.
respondent;
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
respondents.
---------------------------------------------------------------------------
\1\ U.S. Bureau of Labor and Statistics. May 2010 National
Occupational Employment and Wage Estimates. See https://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
respondents)
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel......... 12.2 Minimal Fields: $22.85 $139.38 $106, 938
0.5.
-----------------------------------------------
Optional Fields: 22.85 696.92 534, 690
2.5.
------------------------------------------------------------------
; 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 (https://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 gtr@od.nih.gov,
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]
BILLING CODE 4140-01-P
