Submission for OMB Emergency Review; Comment Request; Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank, 15163-15165 [E8-5824]
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Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
laboratories. Research nurses will
collect blood and urine samples and
return them to the study’s laboratories.
Affected Public: Individuals from
participating communities. Type of
Respondents: Men aged 18+ years and
women aged 18–40 years. Estimated
Number of Respondents: Approximately
500 couples enrolling (minimum of 400
completing the study). Estimated
Number of Response Sets Per
Respondent: 7 per woman and 4 per
man over approximately two years.
Average Burden Hours Per Response: (1)
0.17 hours for completing the screening
instrument; (2) 0.42 hours for baseline
interviews with men and women; (3) 2.5
hours for daily journal while attempting
pregnancy for men and women; (4) 0.38
and 0.7 hours for biospecimen
collection for women and men,
respectively; (5) 2.6 hours for fertility
monitors; (6) 0.27 hours for pregnancy
testing for women; and (7) 0.29 hours
for pregnancy journals for women.
Estimated Total Annual Burden Hours
Requested: 1,640 to 4,950 hours for
female participants and 1,050 to 2,740
hours for male participants depending
upon the length of time required for
pregnancy. There is no cost to
respondents. There are no Capital Costs,
Operating Costs, and/or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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
VerDate Aug<31>2005
18:33 Mar 20, 2008
Jkt 214001
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Germaine M. Buck Louis, Epidemiology
Branch, Division of Epidemiology,
Statistics & Prevention Research,
NICHD, 6100 Executive Blvd., Room
7B03, Rockville, MD 20852, 301–496–
6155. You may also e-mail your request
to louisg@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: March 12, 2008.
Paul L. Johnson,
Project Clearance Liaison, The Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institutes of Health.
[FR Doc. E8–5700 Filed 3–20–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Emergency
Review; Comment Request;
Information Program on Clinical Trials
for Serious and Life-Threatening
Diseases: Maintaining a Databank
Summary: In accordance with Section
3507(j) of the Paperwork Reduction Act
of 1995, the National Institutes of Health
hereby publishes notification of an
Emergency Clearance for the expansion
of the information related to the
‘‘Information Program on Clinical Trials
for Serious and Life-Threatening
Diseases: Maintaining a Databank.’’ The
expanded program will include
information on certain clinical trials of
drugs, biologics, and devices, whether
or not they relate to serious and lifethreatening diseases.
The information collection is essential
to the mission of the FDA and National
Institutes of Health [42 U.S.C.
282(j)(2)(A)(ii)] and is critical to meeting
their roles in the Clinical Trial Registry
that was expanded by Public Law 110–
85, which was enacted on September
27, 2007.
NIH cannot reasonably comply with
the normal clearance procedures for
information collection, because the use
of normal procedures will delay the
collection and hinder the agency in
accomplishing its mission and meeting
new statutory requirements, to the
detriment of the public good.
Compelling reason exists for the
collection of required information for
successful planning and
implementation of the expansion of the
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
15163
Clinical Trial Registry, as described in
Public Law 110–85.
This information collection is
essential to the effective stewardship of
Federal Funds. After consultation with
other agencies and NIH components,
NIH has determined that the
information is not currently available in
any single, reliable, accessible source.
Proposed Collection: Title:
Information Program on Clinical Trials
for Serious and Life-Threatening
Diseases: Maintaining a Databank; Type
of Information Collection Request: New;
Form Number: NA; Need and Use of
Information Collection: In compliance
with provisions of Title VIII of Public
Law 110–85 (Food and Drug
Administration Amendments Act of
2007) the National Institutes of Health is
modifying the clinical trial registry
established under previous law
[ClinicalTrials.gov, established in
response to FDAMA, Section 113]. The
registry collects specified information
on certain clinical trials identified in the
law, with the objective of enhancing
patient enrollment and providing a
mechanism for tracking subsequent
progress of clinical trials, to the benefit
of public health. The registry is widely
used by patients, physicians, and
medical researchers, in particular those
involved in clinical research studies.
Public Law 110–85 expands the scope
of clinical trials that must be registered
in ClinicalTrials.gov to include certain
defined clinical trials of drugs,
biologics, and devices subject to FDA
regulation, regardless of whether they
are related to serious or life-threatening
diseases. It also increases the clinical
trial information (i.e., number of data
elements) that must be submitted as part
of each registration.
Frequency of Response: Responsible
parties for applicable clinical trials must
submit the required information shortly
after the initiation of a trial [by the later
of 21 days after the first patient is
enrolled or December 26, 2007].
Updates to registration records are
thereafter required at least once a year,
unless there are no changes to report.
Changes in recruitment status and
completion of a trial must be reported
not later than 30 days after such events.
Records for trials that were ongoing (as
defined in the Law) as of December 26,
2007 are also required to be updated to
comply with the new registration data
elements, even if they were previously
registered.
Description of Respondents:
Respondents are referred to in the law
as ‘‘responsible parties.’’ The statute
defines the responsible party as: (1) The
sponsor of the clinical trial (as defined
in 21 CFR 50.3) or (2) the principal
E:\FR\FM\21MRN1.SGM
21MRN1
15164
Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
investigator of such clinical trial if so
designated by a sponsor, grantee,
contractor, or awardee, provided that
‘‘the principal investigator is
responsible for conducting the trial, has
access to and control over the data from
the clinical trial, has the right to publish
the results of the trial, and has the
ability to meet all of the requirements’’
for submitting information under the
law.
Estimate of Burden: Under the
clearance to date (OMB No. 0910–0459),
the FDA total hours burden was
200,839. The current annual reporting
burden is shown in Table 1. It is
estimated that approximately 3,500
applicable clinical trials of drugs and
biologics and 445 applicable trials of
devices will be registered annually in
accordance with Public Law 110–85,
Section 801. This estimate is based on
FDA reports that in 2005 some 5,332
new clinical trial protocols were
submitted to its Center for Drug
Evaluation and Research and 474 new
protocols were submitted to the Center
for Biologics Evaluation and Research.
FDA projects that rates of submission
will remain at or near this level in the
near future. An estimated 50% of the
drug and biological protocols received
in 2005, or approximately 2,900
protocols, were for trials involving
assessments of effectiveness, which
would be subject to the provisions of
Title VIII of Public Law 110–85. This
figure was raised to 3,500 drug and
biological trials per year to account for
IND-exempt trials that are required to
register in the expanded registration
data bank, but for which a protocol
might not be sent to FDA. The estimated
445 new applicable device clinical trials
per year includes trials related to premarket applications (approximately 50
applications to FDA containing 75
clinical trial protocols in 2005), 510(k)
submissions (approximately 360
submissions to FDA containing clinical
trial protocols in 2005), and
humanitarian device exemptions (9 in
2005). The estimates of drug, biologic,
and device trials computed using this
approach are consistent with the
numbers of relevant trials that were
registered with the ClinicalTrials.gov
registry in calendar year 2007.
The hour burden accounts for time
required to register trials and provide
necessary updating over the course of
the study. Based on previous
experience, it is estimated that each new
registration record will be updated an
average of 8 times during the course of
the study (e.g., to reflect protocol
changes, additions of investigational
sites, updates of recruitment status, trial
completion). The time to complete an
initial (new) registration (for trials of
drugs, biologics, or devices) is estimated
to be 7 hours (including time to extract,
reformat and submit information which
has already been produced for other
purposes), an increase of 50% above the
4.6 hours that was estimated by FDA for
the smaller set of information collected
under previous law. The time required
for subsequent updates of this
information is expected to be
significantly less than for the original
registration (as less information must be
provided), and is estimated at 2 hours
per update. Applying these figures to
the anticipated numbers of trials
produces a burden estimate for
mandatory, new trial registrations of
90,735 hours.
TABLE 1.—ESTIMATED BURDEN FOR MANDATORY NEW TRIAL REGISTRATIONS
Number of
respondents
Type of respondents
Drugs and Biologics ........................................
3,500
Devices ...........................................................
445
Total .........................................................
3,945
mstockstill on PROD1PC66 with NOTICES
In addition to mandatory
registrations, the registration databank
will also receive a large number of
voluntary submissions of information
from registrants who wish to make their
information public for purposes of
recruitment or compliance with other
policies (e.g., International Committee
of Medical Journal Editors). Voluntary
registration is explicitly authorized in
Public Law 110–85 [Pub. L. 110–85,
Section 801(a), adding new 42 U.S.C.
282(j)(4)(A)] and information is
collected in accordance with the same
specifications established for mandatory
registrations. The number of voluntary
registrations is estimated by subtracting
the anticipated annual number of
VerDate Aug<31>2005
18:33 Mar 20, 2008
Jkt 214001
1
8
1
8
Frm 00045
Annual hour
burden
New .............................................................
Subsequent Updates ..................................
New .............................................................
Subsequent Updates ..................................
7
2
7
2
24,500
56,000
3,115
7,120
.........................................................................
........................
90,735
mandatory registrations from the total
number of trial registrations that is
expected. In calendar year 2007, there
were approximately 13,300 new trials
registered in the ClinicalTrial.gov
registry databank, of which some 8,000
were trials with drugs or biologics as an
intervention, 900 were trials with a
device as an intervention, and 4,400
were other types of trials (e.g.,
observational studies, procedural
interventions, behavioral interventions).
These figures are consistent with the
numbers of trials registered during
calendar year 2005. Subtracting the
anticipated number of mandatory trial
registrations (from Table 1) from the
anticipated number of total registrations
PO 00000
Average time
per response
(hours)
Frequency of
response
Fmt 4703
Sfmt 4703
(2007 statistics) produces estimated
numbers of voluntary registrations of
4,500 trials of drugs and biologics, 455
trials of devices, and 4,400 trials of
other intervention types. To account for
a possible increase in voluntary
submissions resulting from the
heightened level of attention being
devoted to clinical trials information,
these estimates were raised by 20
percent to 5,400 trials of drugs and
biologics, 545 trials of devices, and
5,280 trials of other intervention types.
Assuming the same average time per
response as for mandatory trials, the
annual burden is estimated to be
258,175 hours (Table 2).
E:\FR\FM\21MRN1.SGM
21MRN1
15165
Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
TABLE 2.—ESTIMATED BURDEN FOR VOLUNTARY REPORTING
Number of
respondents
Type of respondents
Drugs and Biologics ........................................
5,400
Devices ...........................................................
545
Other ...............................................................
5,280
Total Voluntary .........................................
11,225
The combined, recurring burden for
mandatory and voluntary reporting
would be the sum of the totals in Tables
1 and 2, or 348,910 hours. This figure
would be expected to decline over time
as registrants become more familiar with
the registration processes and refine
their data submission systems.
During the first year of
implementation, there will be an
additional mandatory reporting burden
associated with the collection of
information for applicable trials of
drugs, biologics, and devices that were
ongoing as of December 26, 2007, but
had been previously registered with
Average time
per response
(hours)
Frequency of response
1
8
1
8
1
8
Annual hour
burden
New .............................................................
Updates .......................................................
New .............................................................
Updates .......................................................
New .............................................................
Updates .......................................................
7
2
7
2
7
2
37,800
86,400
3,815
8,720
36,960
84,480
.........................................................................
........................
258,175
ClinicalTrials.gov. These respondents
have already provided information
collected under the previous OMB
clearance and will provide only the
additional elements subject to this
clearance. The number of trials subject
to this requirement is estimated by
searching the existing ClinicalTrials
registry for ongoing, interventional
Phase 2–4 studies of drugs, biologics,
and devices. Doing so produces an
estimate of 7,650 trials: 7,000 previously
registered trials of drugs and biologics
and 650 previously registered trials of
devices. It is anticipated that
information collection required to bring
these trials into compliance with the
new information collection
requirements will be significantly less
than for a new trial registration and is
estimated as 3 hours. Information for
these trials will need to be updated to
reflect the continued progress of the
trial. The number of updates is
estimated to be 4, which is half of the
updates estimated for new registrations.
Each update is estimated to require 2
hours, consistent with the updates for
newly registered trials. The total burden
associated with the updating of
information for ongoing trials is 84,150
hours, as shown in Table 3.
TABLE 3.—ESTIMATED BURDEN FOR MANDATORY UPDATING OF INFORMATION FOR ONGOING TRIALS
Frequency of response
Average time
per response
(hours)
1 Compliance Update ....................................
4 Subsequent Updates ..................................
1 Compliance Update ....................................
4 Subsequent Updates ..................................
.........................................................................
3
2
3
2
........................
Number of
respondents
Type of respondents
Drugs and Biologics ........................................
7,000
Devices ...........................................................
650
Total ................................................................
7,650
Annual hour
burden
21,000
56,000
1,950
5,200
84,150
mstockstill on PROD1PC66 with NOTICES
There are no Capital Costs, Operating Costs or Maintenance 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.
VerDate Aug<31>2005
18:33 Mar 20, 2008
Jkt 214001
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. All comments
should be sent via e-mail to
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 E-mail your request to
sharlipd@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
best assured of having their full effect if
received within 15 days of the date of
this publication.
Dated: March 14, 2008.
Betsy L. Humphreys,
Deputy Director, National Library of
Medicine, National Institutes of Health.
[FR Doc. E8–5824 Filed 3–20–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 73, Number 56 (Friday, March 21, 2008)]
[Notices]
[Pages 15163-15165]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Emergency Review; Comment Request; Information
Program on Clinical Trials for Serious and Life-Threatening Diseases:
Maintaining a Databank
Summary: In accordance with Section 3507(j) of the Paperwork
Reduction Act of 1995, the National Institutes of Health hereby
publishes notification of an Emergency Clearance for the expansion of
the information related to the ``Information Program on Clinical Trials
for Serious and Life-Threatening Diseases: Maintaining a Databank.''
The expanded program will include information on certain clinical
trials of drugs, biologics, and devices, whether or not they relate to
serious and life-threatening diseases.
The information collection is essential to the mission of the FDA
and National Institutes of Health [42 U.S.C. 282(j)(2)(A)(ii)] and is
critical to meeting their roles in the Clinical Trial Registry that was
expanded by Public Law 110-85, which was enacted on September 27, 2007.
NIH cannot reasonably comply with the normal clearance procedures
for information collection, because the use of normal procedures will
delay the collection and hinder the agency in accomplishing its mission
and meeting new statutory requirements, to the detriment of the public
good. Compelling reason exists for the collection of required
information for successful planning and implementation of the expansion
of the Clinical Trial Registry, as described in Public Law 110-85.
This information collection is essential to the effective
stewardship of Federal Funds. After consultation with other agencies
and NIH components, NIH has determined that the information is not
currently available in any single, reliable, accessible source.
Proposed Collection: Title: Information Program on Clinical Trials
for Serious and Life-Threatening Diseases: Maintaining a Databank; Type
of Information Collection Request: New; Form Number: NA; Need and Use
of Information Collection: In compliance with provisions of Title VIII
of Public Law 110-85 (Food and Drug Administration Amendments Act of
2007) the National Institutes of Health is modifying the clinical trial
registry established under previous law [ClinicalTrials.gov,
established in response to FDAMA, Section 113]. The registry collects
specified information on certain clinical trials identified in the law,
with the objective of enhancing patient enrollment and providing a
mechanism for tracking subsequent progress of clinical trials, to the
benefit of public health. The registry is widely used by patients,
physicians, and medical researchers, in particular those involved in
clinical research studies.
Public Law 110-85 expands the scope of clinical trials that must be
registered in ClinicalTrials.gov to include certain defined clinical
trials of drugs, biologics, and devices subject to FDA regulation,
regardless of whether they are related to serious or life-threatening
diseases. It also increases the clinical trial information (i.e.,
number of data elements) that must be submitted as part of each
registration.
Frequency of Response: Responsible parties for applicable clinical
trials must submit the required information shortly after the
initiation of a trial [by the later of 21 days after the first patient
is enrolled or December 26, 2007]. Updates to registration records are
thereafter required at least once a year, unless there are no changes
to report. Changes in recruitment status and completion of a trial must
be reported not later than 30 days after such events. Records for
trials that were ongoing (as defined in the Law) as of December 26,
2007 are also required to be updated to comply with the new
registration data elements, even if they were previously registered.
Description of Respondents: Respondents are referred to in the law
as ``responsible parties.'' The statute defines the responsible party
as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3)
or (2) the principal
[[Page 15164]]
investigator of such clinical trial if so designated by a sponsor,
grantee, contractor, or awardee, provided that ``the principal
investigator is responsible for conducting the trial, has access to and
control over the data from the clinical trial, has the right to publish
the results of the trial, and has the ability to meet all of the
requirements'' for submitting information under the law.
Estimate of Burden: Under the clearance to date (OMB No. 0910-
0459), the FDA total hours burden was 200,839. The current annual
reporting burden is shown in Table 1. It is estimated that
approximately 3,500 applicable clinical trials of drugs and biologics
and 445 applicable trials of devices will be registered annually in
accordance with Public Law 110-85, Section 801. This estimate is based
on FDA reports that in 2005 some 5,332 new clinical trial protocols
were submitted to its Center for Drug Evaluation and Research and 474
new protocols were submitted to the Center for Biologics Evaluation and
Research. FDA projects that rates of submission will remain at or near
this level in the near future. An estimated 50% of the drug and
biological protocols received in 2005, or approximately 2,900
protocols, were for trials involving assessments of effectiveness,
which would be subject to the provisions of Title VIII of Public Law
110-85. This figure was raised to 3,500 drug and biological trials per
year to account for IND-exempt trials that are required to register in
the expanded registration data bank, but for which a protocol might not
be sent to FDA. The estimated 445 new applicable device clinical trials
per year includes trials related to pre-market applications
(approximately 50 applications to FDA containing 75 clinical trial
protocols in 2005), 510(k) submissions (approximately 360 submissions
to FDA containing clinical trial protocols in 2005), and humanitarian
device exemptions (9 in 2005). The estimates of drug, biologic, and
device trials computed using this approach are consistent with the
numbers of relevant trials that were registered with the
ClinicalTrials.gov registry in calendar year 2007.
The hour burden accounts for time required to register trials and
provide necessary updating over the course of the study. Based on
previous experience, it is estimated that each new registration record
will be updated an average of 8 times during the course of the study
(e.g., to reflect protocol changes, additions of investigational sites,
updates of recruitment status, trial completion). The time to complete
an initial (new) registration (for trials of drugs, biologics, or
devices) is estimated to be 7 hours (including time to extract,
reformat and submit information which has already been produced for
other purposes), an increase of 50% above the 4.6 hours that was
estimated by FDA for the smaller set of information collected under
previous law. The time required for subsequent updates of this
information is expected to be significantly less than for the original
registration (as less information must be provided), and is estimated
at 2 hours per update. Applying these figures to the anticipated
numbers of trials produces a burden estimate for mandatory, new trial
registrations of 90,735 hours.
Table 1.--Estimated Burden for Mandatory New Trial Registrations
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of response per response Annual hour
respondents (hours) burden
----------------------------------------------------------------------------------------------------------------
Drugs and Biologics................... 3,500 1 New................... 7 24,500
8 Subsequent Updates.... 2 56,000
Devices............................... 445 1 New................... 7 3,115
8 Subsequent Updates.... 2 7,120
-------------------------------------------------------------------------
Total............................. 3,945 ........................ .............. 90,735
----------------------------------------------------------------------------------------------------------------
In addition to mandatory registrations, the registration databank
will also receive a large number of voluntary submissions of
information from registrants who wish to make their information public
for purposes of recruitment or compliance with other policies (e.g.,
International Committee of Medical Journal Editors). Voluntary
registration is explicitly authorized in Public Law 110-85 [Pub. L.
110-85, Section 801(a), adding new 42 U.S.C. 282(j)(4)(A)] and
information is collected in accordance with the same specifications
established for mandatory registrations. The number of voluntary
registrations is estimated by subtracting the anticipated annual number
of mandatory registrations from the total number of trial registrations
that is expected. In calendar year 2007, there were approximately
13,300 new trials registered in the ClinicalTrial.gov registry
databank, of which some 8,000 were trials with drugs or biologics as an
intervention, 900 were trials with a device as an intervention, and
4,400 were other types of trials (e.g., observational studies,
procedural interventions, behavioral interventions). These figures are
consistent with the numbers of trials registered during calendar year
2005. Subtracting the anticipated number of mandatory trial
registrations (from Table 1) from the anticipated number of total
registrations (2007 statistics) produces estimated numbers of voluntary
registrations of 4,500 trials of drugs and biologics, 455 trials of
devices, and 4,400 trials of other intervention types. To account for a
possible increase in voluntary submissions resulting from the
heightened level of attention being devoted to clinical trials
information, these estimates were raised by 20 percent to 5,400 trials
of drugs and biologics, 545 trials of devices, and 5,280 trials of
other intervention types. Assuming the same average time per response
as for mandatory trials, the annual burden is estimated to be 258,175
hours (Table 2).
[[Page 15165]]
Table 2.--Estimated Burden for Voluntary Reporting
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of response per response Annual hour
respondents (hours) burden
----------------------------------------------------------------------------------------------------------------
Drugs and Biologics................... 5,400 1 New................... 7 37,800
8 Updates............... 2 86,400
Devices............................... 545 1 New................... 7 3,815
8 Updates............... 2 8,720
Other................................. 5,280 1 New................... 7 36,960
8 Updates............... 2 84,480
-------------------------------------------------------------------------
Total Voluntary................... 11,225 ........................ .............. 258,175
----------------------------------------------------------------------------------------------------------------
The combined, recurring burden for mandatory and voluntary
reporting would be the sum of the totals in Tables 1 and 2, or 348,910
hours. This figure would be expected to decline over time as
registrants become more familiar with the registration processes and
refine their data submission systems.
During the first year of implementation, there will be an
additional mandatory reporting burden associated with the collection of
information for applicable trials of drugs, biologics, and devices that
were ongoing as of December 26, 2007, but had been previously
registered with ClinicalTrials.gov. These respondents have already
provided information collected under the previous OMB clearance and
will provide only the additional elements subject to this clearance.
The number of trials subject to this requirement is estimated by
searching the existing ClinicalTrials registry for ongoing,
interventional Phase 2-4 studies of drugs, biologics, and devices.
Doing so produces an estimate of 7,650 trials: 7,000 previously
registered trials of drugs and biologics and 650 previously registered
trials of devices. It is anticipated that information collection
required to bring these trials into compliance with the new information
collection requirements will be significantly less than for a new trial
registration and is estimated as 3 hours. Information for these trials
will need to be updated to reflect the continued progress of the trial.
The number of updates is estimated to be 4, which is half of the
updates estimated for new registrations. Each update is estimated to
require 2 hours, consistent with the updates for newly registered
trials. The total burden associated with the updating of information
for ongoing trials is 84,150 hours, as shown in Table 3.
Table 3.--Estimated Burden for Mandatory Updating of Information for Ongoing Trials
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of response per response Annual hour
respondents (hours) burden
----------------------------------------------------------------------------------------------------------------
Drugs and Biologics................... 7,000 1 Compliance Update..... 3 21,000
4 Subsequent Updates.... 2 56,000
Devices............................... 650 1 Compliance Update..... 3 1,950
4 Subsequent Updates.... 2 5,200
Total................................. 7,650 ........................ .............. 84,150
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There are no Capital Costs, Operating Costs or Maintenance 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. All comments should be sent via e-mail to 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 E-mail 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 15 days
of the date of this publication.
Dated: March 14, 2008.
Betsy L. Humphreys,
Deputy Director, National Library of Medicine, National Institutes of
Health.
[FR Doc. E8-5824 Filed 3-20-08; 8:45 am]
BILLING CODE 4140-01-P
