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Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
Clinical Trial Registry, as described in
laboratories. Research nurses will to obtain a copy of the data collection
Public Law 110鈥?85.
collect blood and urine samples and plans and instruments, contact: Dr.
This information collection is
return them to the study鈥檚 laboratories. Germaine M. Buck Louis, Epidemiology
essential to the effective stewardship of
Affected Public: Individuals from Branch, Division of Epidemiology,
Federal Funds. After consultation with
participating communities. Type of Statistics & Prevention Research,
other agencies and NIH components,
Respondents: Men aged 18+ years and NICHD, 6100 Executive Blvd., Room
NIH has determined that the
women aged 18鈥?40 years. Estimated 7B03, Rockville, MD 20852, 301鈥?496鈥?
information is not currently available in
Number of Respondents: Approximately 6155. You may also e-mail your request
any single, reliable, accessible source.
500 couples enrolling (minimum of 400 to louisg@mail.nih.gov.
Proposed Collection: Title:
completing the study). Estimated Comments Due Date: Comments
Information Program on Clinical Trials
Number of Response Sets Per regarding this information collection are
for Serious and Life-Threatening
Respondent: 7 per woman and 4 per best assured of having their full effect if
Diseases: Maintaining a Databank; Type
man over approximately two years. received within 30 days of the date of
of Information Collection Request: New;
Average Burden Hours Per Response: (1) this publication.
Form Number: NA; Need and Use of
0.17 hours for completing the screening Dated: March 12, 2008.
Information Collection: In compliance
instrument; (2) 0.42 hours for baseline
Paul L. Johnson, with provisions of Title VIII of Public
interviews with men and women; (3) 2.5
Project Clearance Liaison, The Eunice Law 110鈥?85 (Food and Drug
hours for daily journal while attempting
Kennedy Shriver National Institute of Child Administration Amendments Act of
pregnancy for men and women; (4) 0.38 Health and Human Development, National
2007) the National Institutes of Health is
and 0.7 hours for biospecimen Institutes of Health.
modifying the clinical trial registry
collection for women and men, [FR Doc. E8鈥?5700 Filed 3鈥?20鈥?08; 8:45 am]
established under previous law
respectively; (5) 2.6 hours for fertility
BILLING CODE 4140鈥?01鈥揚 [ClinicalTrials.gov, established in
monitors; (6) 0.27 hours for pregnancy
response to FDAMA, Section 113]. The
testing for women; and (7) 0.29 hours
registry collects specified information
for pregnancy journals for women. DEPARTMENT OF HEALTH AND on certain clinical trials identified in the
Estimated Total Annual Burden Hours HUMAN SERVICES law, with the objective of enhancing
Requested: 1,640 to 4,950 hours for
patient enrollment and providing a
female participants and 1,050 to 2,740 National Institutes of Health
mechanism for tracking subsequent
hours for male participants depending
progress of clinical trials, to the benefit
upon the length of time required for Submission for OMB Emergency
of public health. The registry is widely
pregnancy. There is no cost to Review; Comment Request;
used by patients, physicians, and
respondents. There are no Capital Costs, Information Program on Clinical Trials
medical researchers, in particular those
Operating Costs, and/or Maintenance for Serious and Life-Threatening
involved in clinical research studies.
Costs to report. Diseases: Maintaining a Databank
Public Law 110鈥?85 expands the scope
Request for Comments: Written
Summary: In accordance with Section of clinical trials that must be registered
comments and/or suggestions from the
3507(j) of the Paperwork Reduction Act in ClinicalTrials.gov to include certain
public and affected agencies are invited
of 1995, the National Institutes of Health defined clinical trials of drugs,
on one or more of the following points:
hereby publishes notification of an biologics, and devices subject to FDA
(1) Evaluate whether the proposed
Emergency Clearance for the expansion regulation, regardless of whether they
collection of information is necessary
of the information related to the are related to serious or life-threatening
for the proper performance of the
鈥樷?業nformation Program on Clinical Trials diseases. It also increases the clinical
function of the agency, including
for Serious and Life-Threatening trial information (i.e., number of data
whether the information will have
Diseases: Maintaining a Databank.鈥欌?? The elements) that must be submitted as part
practical utility; (2) Evaluate the
expanded program will include of each registration.
accuracy of the agency鈥檚 estimate of the
Frequency of Response: Responsible
information on certain clinical trials of
burden of the proposed collection of
parties for applicable clinical trials must
drugs, biologics, and devices, whether
information, including the validity of
submit the required information shortly
or not they relate to serious and life-
the methodology and assumptions used;
after the initiation of a trial [by the later
threatening diseases.
(3) Enhance the quality, utility, and
The information collection is essential of 21 days after the first patient is
clarity of the information to be
to the mission of the FDA and National enrolled or December 26, 2007].
collected; and (4) Minimize the burden
Institutes of Health [42 U.S.C. Updates to registration records are
of the collection of information on those
282(j)(2)(A)(ii)] and is critical to meeting thereafter required at least once a year,
who are to respond, including the use
their roles in the Clinical Trial Registry unless there are no changes to report.
of appropriate automated, electronic,
that was expanded by Public Law 110鈥? Changes in recruitment status and
mechanical, or other technological
85, which was enacted on September completion of a trial must be reported
collection techniques or other forms of
27, 2007. not later than 30 days after such events.
information technology.
NIH cannot reasonably comply with Records for trials that were ongoing (as
Direct Comments to OMB: Written
the normal clearance procedures for defined in the Law) as of December 26,
comments and/or suggestions regarding
information collection, because the use
the item(s) contained in this notice, 2007 are also required to be updated to
of normal procedures will delay the
especially regarding the estimated comply with the new registration data
collection and hinder the agency in
public burden and associated response elements, even if they were previously
accomplishing its mission and meeting
time, should be directed to the: Office registered.
mstockstill on PROD1PC66 with NOTICES
Description of Respondents:
new statutory requirements, to the
of Management and Budget, Office of
Respondents are referred to in the law
detriment of the public good.
Regulatory Affairs,
as 鈥樷?榬esponsible parties.鈥欌?? The statute
Compelling reason exists for the
OIRA_submission@omb.eop.gov, or by
defines the responsible party as: (1) The
collection of required information for
fax to 202鈥?395鈥?6974, Attention: Desk
sponsor of the clinical trial (as defined
successful planning and
Officer for NIH. To request more
in 21 CFR 50.3) or (2) the principal
implementation of the expansion of the
information on the proposed project or
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15164 Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
investigator of such clinical trial if so near future. An estimated 50% of the necessary updating over the course of
designated by a sponsor, grantee, drug and biological protocols received the study. Based on previous
contractor, or awardee, provided that in 2005, or approximately 2,900 experience, it is estimated that each new
鈥樷?榯he principal investigator is protocols, were for trials involving registration record will be updated an
responsible for conducting the trial, has assessments of effectiveness, which average of 8 times during the course of
access to and control over the data from would be subject to the provisions of the study (e.g., to reflect protocol
the clinical trial, has the right to publish Title VIII of Public Law 110鈥?85. This changes, additions of investigational
the results of the trial, and has the figure was raised to 3,500 drug and sites, updates of recruitment status, trial
ability to meet all of the requirements鈥欌?? biological trials per year to account for completion). The time to complete an
for submitting information under the IND-exempt trials that are required to
initial (new) registration (for trials of
law. register in the expanded registration
drugs, biologics, or devices) is estimated
Estimate of Burden: Under the data bank, but for which a protocol
to be 7 hours (including time to extract,
clearance to date (OMB No. 0910鈥?0459), might not be sent to FDA. The estimated
reformat and submit information which
the FDA total hours burden was 445 new applicable device clinical trials
has already been produced for other
200,839. The current annual reporting per year includes trials related to pre-
purposes), an increase of 50% above the
burden is shown in Table 1. It is market applications (approximately 50
4.6 hours that was estimated by FDA for
estimated that approximately 3,500 applications to FDA containing 75
the smaller set of information collected
applicable clinical trials of drugs and clinical trial protocols in 2005), 510(k)
under previous law. The time required
biologics and 445 applicable trials of submissions (approximately 360
for subsequent updates of this
devices will be registered annually in submissions to FDA containing clinical
accordance with Public Law 110鈥?85, information is expected to be
trial protocols in 2005), and
Section 801. This estimate is based on humanitarian device exemptions (9 in significantly less than for the original
FDA reports that in 2005 some 5,332 2005). The estimates of drug, biologic, registration (as less information must be
new clinical trial protocols were and device trials computed using this provided), and is estimated at 2 hours
submitted to its Center for Drug approach are consistent with the per update. Applying these figures to
Evaluation and Research and 474 new numbers of relevant trials that were the anticipated numbers of trials
protocols were submitted to the Center registered with the ClinicalTrials.gov produces a burden estimate for
for Biologics Evaluation and Research. registry in calendar year 2007. mandatory, new trial registrations of
FDA projects that rates of submission The hour burden accounts for time 90,735 hours.
will remain at or near this level in the required to register trials and provide
TABLE 1.鈥擡STIMATED BURDEN FOR MANDATORY NEW TRIAL REGISTRATIONS
Average time
Number of Frequency of Annual hour
Type of respondents per response
respondents response burden
(hours)
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 mandatory registrations from the total (2007 statistics) produces estimated
registrations, the registration databank number of trial registrations that is numbers of voluntary registrations of
will also receive a large number of expected. In calendar year 2007, there 4,500 trials of drugs and biologics, 455
voluntary submissions of information were approximately 13,300 new trials trials of devices, and 4,400 trials of
from registrants who wish to make their registered in the ClinicalTrial.gov other intervention types. To account for
information public for purposes of registry databank, of which some 8,000 a possible increase in voluntary
recruitment or compliance with other were trials with drugs or biologics as an submissions resulting from the
policies (e.g., International Committee intervention, 900 were trials with a heightened level of attention being
of Medical Journal Editors). Voluntary device as an intervention, and 4,400 devoted to clinical trials information,
registration is explicitly authorized in were other types of trials (e.g.,
these estimates were raised by 20
Public Law 110鈥?85 [Pub. L. 110鈥?85, observational studies, procedural
percent to 5,400 trials of drugs and
Section 801(a), adding new 42 U.S.C. interventions, behavioral interventions).
biologics, 545 trials of devices, and
282(j)(4)(A)] and information is These figures are consistent with the
5,280 trials of other intervention types.
collected in accordance with the same numbers of trials registered during
Assuming the same average time per
specifications established for mandatory calendar year 2005. Subtracting the
response as for mandatory trials, the
registrations. The number of voluntary anticipated number of mandatory trial
annual burden is estimated to be
registrations is estimated by subtracting registrations (from Table 1) from the
258,175 hours (Table 2).
the anticipated annual number of anticipated number of total registrations
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Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
TABLE 2.鈥擡STIMATED BURDEN FOR VOLUNTARY REPORTING
Average time
Number of Annual hour
Type of respondents Frequency of response per response
respondents burden
(hours)
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
these trials into compliance with the
ClinicalTrials.gov. These respondents
The combined, recurring burden for
new information collection
have already provided information
mandatory and voluntary reporting
requirements will be significantly less
collected under the previous OMB
would be the sum of the totals in Tables
than for a new trial registration and is
clearance and will provide only the
1 and 2, or 348,910 hours. This figure
estimated as 3 hours. Information for
additional elements subject to this
would be expected to decline over time
these trials will need to be updated to
clearance. The number of trials subject
as registrants become more familiar with
reflect the continued progress of the
to this requirement is estimated by
the registration processes and refine
trial. The number of updates is
searching the existing ClinicalTrials
their data submission systems.
estimated to be 4, which is half of the
registry for ongoing, interventional
During the first year of
updates estimated for new registrations.
Phase 2鈥?4 studies of drugs, biologics,
implementation, there will be an
Each update is estimated to require 2
and devices. Doing so produces an
additional mandatory reporting burden
hours, consistent with the updates for
estimate of 7,650 trials: 7,000 previously
associated with the collection of
newly registered trials. The total burden
registered trials of drugs and biologics
information for applicable trials of
associated with the updating of
and 650 previously registered trials of
drugs, biologics, and devices that were
information for ongoing trials is 84,150
devices. It is anticipated that
ongoing as of December 26, 2007, but
hours, as shown in Table 3.
information collection required to bring
had been previously registered with
TABLE 3.鈥擡STIMATED BURDEN FOR MANDATORY UPDATING OF INFORMATION FOR ONGOING TRIALS
Average time
Number of Annual hour
Type of respondents Frequency of response per response
respondents burden
(hours)
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
There are no Capital Costs, Operating Costs or Maintenance Costs to report.
best assured of having their full effect if
Direct Comments to OMB: Written
Request for Comments: Written
received within 15 days of the date of
comments and/or suggestions regarding
comments and/or suggestions from the
this publication.
the item(s) contained in this notice,
public and affected agencies should
especially regarding the estimated
address one or more of the following Dated: March 14, 2008.
public burden and associated response
points: (1) Evaluate whether the Betsy L. Humphreys,
time, should be directed to the Office of
proposed collection of information is Deputy Director, National Library of
Management and Budget, Office of
necessary for the proper performance of Medicine, National Institutes of Health.
Regulatory Affairs. All comments
the function of the agency, including [FR Doc. E8鈥?5824 Filed 3鈥?20鈥?08; 8:45 am]
should be sent via e-mail to
whether the information will have BILLING CODE 4140鈥?01鈥揚
OIRA_submission@omb.eop.gov or by
practical utility; (2) Evaluate the
fax to 202鈥?395鈥?6974, Attention: Desk
accuracy of the agency鈥檚 estimate of the
Officer for NIH. To request more
burden of the proposed collection of DEPARTMENT OF HEALTH AND
information on the proposed project or
information, including the validity of HUMAN SERVICES
to obtain a copy of the data collection
the methodology and assumptions used;
plans and instruments, contact: David National Institutes of Health
(3) Enhance the quality, utility, and
Sharlip, National Library of Medicine,
clarity of the information to be
Center for Scientific Review; Notice of
Building 38A, Room B2N12, 8600
collected; and (4) Minimize the burden
Closed Meetings
Rockville Pike, Bethesda, MD 20894, or
mstockstill on PROD1PC66 with NOTICES
of the collection of information on those
call non-toll free number 301鈥?402鈥?9680
who are to respond, including the use Pursuant to section 10(d) of the
or E-mail your request to
of appropriate automated, electronic, Federal Advisory Committee Act, as
sharlipd@mail.nih.gov.
mechanical, or other technological amended (5 U.S.C. Appendix 2), notice
collection techniques or other forms of Comments Due Date: Comments is hereby given of the following
regarding this information collection are
information technology. meetings.
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