Submission for OMB Review; Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank, 22578-22579 [2012-9083]
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Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Notices
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Arthur L. Loomis, II, Patricia A.
Loomis, Genevieve E. Loomis, and Julia
P. Loomis, all of Niskayuna, New York;
Florence Porter Loomis, Frederick S.
Loomis, Anne M. Loomis, and J. Porter
Loomis, all of Pratt, Kansas; Howard K.
Loomis, Jr., Karen P. Loomis, Katherine
P. Loomis, Margaret P. Loomis, and
Victoria K. Loomis, all of Los Gatos;
California, as individuals and/or
trustees of the 2011 Arthur L. Loomis, II
Gift Trust, the Julia P. Loomis Revocable
Trust, the Arthur L. Loomis, II Revocable
Trust, the Genevieve E. Loomis
Revocable Trust, all of Niskayuna, New
York; the Howard K. Loomis Revocable
Trust, the 2010 Howard K. Loomis
Irrevocable Family Trust, the Porter
Legacy Trust, Florence Porter Loomis
Trust, the 2010 Florence Porter Loomis
Irrevocable Family Trust, the 2011
Frederick S. Loomis Gift Trust, the 2011
J. Porter Loomis Gift Trust, all of Pratt,
Kansas; the 2011 Howard K. Loomis Jr.
Gift Trust, The Loomis 1993 Revocable
Trust, both of Los Gatos, California; and
Flopper, L.P., How-Kan, L.P., and
Driftwood, LLC, all of Pratt, Kansas; and
all as members of the Loomis Family
Group, to retain control of Krey Co. Ltd.,
and thereby indirectly retain control of
The Peoples Bank, both in Pratt, Kansas.
Comments on this application must
be received by April 20, 2012.
Board of Governors of the Federal Reserve
System, April 11, 2012.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2012–9033 Filed 4–13–12; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Library of Medicine (NLM), 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 February 9, 2012 (Vol. 77,
No. 27, p. 6808) and allowed 60-days for
public comment. A single public
emcdonald on DSK29S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:39 Apr 13, 2012
Jkt 226001
comment was 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:
Information Program on Clinical Trials:
Maintaining a Registry and Results
Databank; Type of Information
Collection Request: Revision of
currently approved collection [OMB No.
0925–0586, expiration date 04/30/2012],
Form Number: NA; Need and Use of
Information Collection: The National
Institutes of Health operates
ClinicalTrials.gov, which was
established as a clinical trial registry
under section 113 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies,
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered voluntarily, FDAAA requires
the registration of certain applicable
clinical trials of drugs and devices and
the submission of results information
for completed applicable clinical trials
of drugs and devices that are approved,
licensed, or cleared by the Food and
Drug Administration. Beginning in
2009, results information was required
to include information about serious
and frequent adverse events. As the
existing PRA clearance for this
information collection nears expiration,
we are making a limited number of
revisions to include additional data
elements that may be voluntarily
submitted to describe and aid in the
interpretation of any submitted adverse
event information, to facilitate the
registration of patient registries, and to
account for the burden of establishing
an account with the ClinicalTrials.gov
Protocol Registration System (PRS).
Frequency of Response: For clinical
trials that are subject to FDAAA,
responsible parties must register once,
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
not later than 21 days after enrolling the
first subject. Updates to submitted
information are required at least once a
year, if there are changes to report,
although changes in recruitment status
and completion of a trial must be
reported not later than 30 days after
such events. Results information is to be
submitted not later than 12 months after
the completion date (as defined in the
law), but can be delayed under certain
circumstances. Other clinical studies
also register once, at their inception,
and are requested to update information
annually, as necessary. An organization
must establish a PRS account one time
in order to register studies (and submit
results) with ClinicalTrials.gov.
Description of Respondents:
Respondents include sponsors or
principal investigators of clinical
studies. Those subject to FDAAA are
referred to as ‘‘responsible parties,’’
which are defined as sponsors of the
clinical trial (as defined in 21 CFR 50.3)
or designated principal investigators
who meet requirements specified in the
law. Estimate of Burden: The burden
associated with this information
collection is calculated in three parts:
the burden associated with the one-time
process of applying for a PRS account at
ClinicalTrials.gov; the burden
associated with registration; and the
burden associated with the submission
of results information, including
adverse events. These information
collections will occur at different times,
but the registration and results
information will be integrated into a
single record for each clinical trial,
which is entered through the PRS
account. Based on data from 2011, we
estimate that 5,500 new PRS account
applications will be submitted annually.
The time necessary to collect the
required information and enter it into a
new application form is estimated at 15
minutes. Using these figures, we
estimate the total annual burden of
submitting an application for a new PRS
account to be 1,375 hours (5,500
applications per year times 0.25 hours
per application). To estimate the annual
reporting burden for registration, we
examined the number of clinical studies
registered annually with
ClinicalTrials.gov and found an average
of 17,000 registrations per year since the
enactment of FDAAA. From this total,
we estimate that approximately 5,000
studies would be applicable clinical
trials of drugs (including biological
products) and 500 would be applicable
trials of devices subject to FDAAA. The
remaining 11,500 studies would be
registered voluntarily. We estimate the
time to complete an initial registration
E:\FR\FM\16APN1.SGM
16APN1
emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Notices
to be 7 hours (including time to extract,
reformat and submit information which
has already been produced for other
purposes). This estimate is consistent
with that used on the previous PRA
clearance and incorporates 4 hours for
data extraction and 3 hours for
reformatting. Based on previous
experience, we estimate that each
registration record will be updated an
average of eight times and that each
update takes approximately 2 hours.
Applying these figures to the estimated
number of trials to be registered per year
produces an annual burden estimate of
391,000 hours. Of this total, 126,500
hours are associated with the mandatory
registration of trials subject to FDAAA,
and 264,500 hours are associated with
voluntary registrations. The burden of
results submission consists of the time
and effort needed to summarize
information from a clinical trial, format
it, and enter it into the databank. We
estimate that of the 5,500 applicable
clinical trials that are registered each
year, approximately 1,845 will be
required to submit results each year
(1,500 trials of drugs and biological
products, and 345 trials of devices). We
estimate that each results record will
submitted once and updated twice to
reflect changes in the data analysis,
additional results of subsequent prespecified outcome measures, or
additional adverse event information.
Based on information available from
various organizations about results
submission times, comments made at a
public meeting held in April 2009,
responses to estimates in previous OMB
clearance documents (73 FR 58972, Oct.
8, 2008), and feedback from respondents
who have submitted results to
ClinicalTrials.gov, we have increased
our estimate of the average response
time to 25 hours from the 10 hour
estimate included in the previous OMB
clearance request. We estimate that
updates take 8 hours, an increase over
the 5 hour estimate included in the
previous OMB clearance request for
adverse event information. In addition,
we estimate that 3,655 trials per year
will submit certifications to
ClinicalTrials.gov indicating that they
qualify for delayed results submission,
and another 200 trials will request
extensions to the submission deadline
for good cause, as permitted by FDAAA.
We expect that it would take no more
than 30 minutes for a responsible party
to determine that a certification is
required and to submit the necessary
information through ClinicalTrials.gov.
For extension requests, we estimate that
the time to prepare a request and submit
it to ClinicalTrials.gov would be no
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14:39 Apr 13, 2012
Jkt 226001
more than 2 hours. Using these figures,
we estimate the annualized hourly
burden for submitting results
information, certifications, and
extension requests to be 77,872.5 hours.
There are no capital costs to report.
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,
OIRA_submission@omb.eop.gov 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 instruments, contact: David
Sharlip, National Library of Medicine,
Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or
call non-toll free number 301–402–9680
or email your request to
sharlipd@mail.nih.gov.
Comments 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: April 10, 2012.
David H. Sharlip,
NLM Project Clearance Liaison, National
Library of Medicine, National Institutes of
Health.
[FR Doc. 2012–9083 Filed 4–13–12; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
22579
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 USC,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel ETechnology Tools for Extending the Reach of
Prevention Interventions in Rural and
Remote Locations (5567)
Date: April 30, 2012.
Time: 1:30 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer,
Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, 6001 Executive Blvd., Room 4229,
MSC 9550, Bethesda, MD 20892–9550, 301–
402–2105, rogersn2@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel Rapid
Portable Devices to Measure Drug Use (1206).
Date: May 1, 2012.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: April 10, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–9055 Filed 4–13–12; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Notices]
[Pages 22578-22579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9083]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Information Program
on Clinical Trials: Maintaining a Registry and Results Databank
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Library of Medicine (NLM), 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 February
9, 2012 (Vol. 77, No. 27, p. 6808) and allowed 60-days for public
comment. A single public comment was 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: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank; Type of Information
Collection Request: Revision of currently approved collection [OMB No.
0925-0586, expiration date 04/30/2012], Form Number: NA; Need and Use
of Information Collection: The National Institutes of Health operates
ClinicalTrials.gov, which was established as a clinical trial registry
under section 113 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) and was expanded to include a results data
bank by Title VIII of the Food and Drug Administration Amendments Act
of 2007 (FDAAA). ClinicalTrials.gov collects registration and results
information for clinical trials and other types of clinical studies
(e.g., observational studies and patient registries) with the
objectives of enhancing patient enrollment and providing a mechanism
for tracking subsequent progress of clinical studies, to the benefit of
public health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered voluntarily, FDAAA requires the
registration of certain applicable clinical trials of drugs and devices
and the submission of results information for completed applicable
clinical trials of drugs and devices that are approved, licensed, or
cleared by the Food and Drug Administration. Beginning in 2009, results
information was required to include information about serious and
frequent adverse events. As the existing PRA clearance for this
information collection nears expiration, we are making a limited number
of revisions to include additional data elements that may be
voluntarily submitted to describe and aid in the interpretation of any
submitted adverse event information, to facilitate the registration of
patient registries, and to account for the burden of establishing an
account with the ClinicalTrials.gov Protocol Registration System (PRS).
Frequency of Response: For clinical trials that are subject to FDAAA,
responsible parties must register once, not later than 21 days after
enrolling the first subject. Updates to submitted information are
required at least once a year, if there are changes to report, although
changes in recruitment status and completion of a trial must be
reported not later than 30 days after such events. Results information
is to be submitted not later than 12 months after the completion date
(as defined in the law), but can be delayed under certain
circumstances. Other clinical studies also register once, at their
inception, and are requested to update information annually, as
necessary. An organization must establish a PRS account one time in
order to register studies (and submit results) with ClinicalTrials.gov.
Description of Respondents: Respondents include sponsors or
principal investigators of clinical studies. Those subject to FDAAA are
referred to as ``responsible parties,'' which are defined as sponsors
of the clinical trial (as defined in 21 CFR 50.3) or designated
principal investigators who meet requirements specified in the law.
Estimate of Burden: The burden associated with this information
collection is calculated in three parts: the burden associated with the
one-time process of applying for a PRS account at ClinicalTrials.gov;
the burden associated with registration; and the burden associated with
the submission of results information, including adverse events. These
information collections will occur at different times, but the
registration and results information will be integrated into a single
record for each clinical trial, which is entered through the PRS
account. Based on data from 2011, we estimate that 5,500 new PRS
account applications will be submitted annually. The time necessary to
collect the required information and enter it into a new application
form is estimated at 15 minutes. Using these figures, we estimate the
total annual burden of submitting an application for a new PRS account
to be 1,375 hours (5,500 applications per year times 0.25 hours per
application). To estimate the annual reporting burden for registration,
we examined the number of clinical studies registered annually with
ClinicalTrials.gov and found an average of 17,000 registrations per
year since the enactment of FDAAA. From this total, we estimate that
approximately 5,000 studies would be applicable clinical trials of
drugs (including biological products) and 500 would be applicable
trials of devices subject to FDAAA. The remaining 11,500 studies would
be registered voluntarily. We estimate the time to complete an initial
registration
[[Page 22579]]
to be 7 hours (including time to extract, reformat and submit
information which has already been produced for other purposes). This
estimate is consistent with that used on the previous PRA clearance and
incorporates 4 hours for data extraction and 3 hours for reformatting.
Based on previous experience, we estimate that each registration record
will be updated an average of eight times and that each update takes
approximately 2 hours. Applying these figures to the estimated number
of trials to be registered per year produces an annual burden estimate
of 391,000 hours. Of this total, 126,500 hours are associated with the
mandatory registration of trials subject to FDAAA, and 264,500 hours
are associated with voluntary registrations. The burden of results
submission consists of the time and effort needed to summarize
information from a clinical trial, format it, and enter it into the
databank. We estimate that of the 5,500 applicable clinical trials that
are registered each year, approximately 1,845 will be required to
submit results each year (1,500 trials of drugs and biological
products, and 345 trials of devices). We estimate that each results
record will submitted once and updated twice to reflect changes in the
data analysis, additional results of subsequent pre-specified outcome
measures, or additional adverse event information. Based on information
available from various organizations about results submission times,
comments made at a public meeting held in April 2009, responses to
estimates in previous OMB clearance documents (73 FR 58972, Oct. 8,
2008), and feedback from respondents who have submitted results to
ClinicalTrials.gov, we have increased our estimate of the average
response time to 25 hours from the 10 hour estimate included in the
previous OMB clearance request. We estimate that updates take 8 hours,
an increase over the 5 hour estimate included in the previous OMB
clearance request for adverse event information. In addition, we
estimate that 3,655 trials per year will submit certifications to
ClinicalTrials.gov indicating that they qualify for delayed results
submission, and another 200 trials will request extensions to the
submission deadline for good cause, as permitted by FDAAA. We expect
that it would take no more than 30 minutes for a responsible party to
determine that a certification is required and to submit the necessary
information through ClinicalTrials.gov. For extension requests, we
estimate that the time to prepare a request and submit it to
ClinicalTrials.gov would be no more than 2 hours. Using these figures,
we estimate the annualized hourly burden for submitting results
information, certifications, and extension requests to be 77,872.5
hours. There are no capital costs to report.
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, OIRA_submission@omb.eop.gov 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
instruments, contact: David Sharlip, National Library of Medicine,
Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or
call non-toll free number 301-402-9680 or email your request to
sharlipd@mail.nih.gov.
Comments 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: April 10, 2012.
David H. Sharlip,
NLM Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2012-9083 Filed 4-13-12; 8:45 am]
BILLING CODE 4140-01-P
