Approved
consistent with previous terms of clearance: This collection is
approved consistent with the agreement that NIH will continue to
work with OMB and other interested agencies as they move forward
with the rule making process that will eventually define the
adverse event reporting framework in response to U.S. Public Law
110-85 (i.e., determining the best method for including in the
registry and results databank appropriate results information on
serious adverse and frequent adverse events.) These terms of
clearance do not preclude the option of NIH using the FDAAA default
as a starting point for adverse event reporting. OMB understands
that NIH will seek public comments through rulemaking and
incorporate prior experience with the optional reporting system to
ensure that the default elements are incorporated and displayed in
an appropriate and meaningful way.
Inventory as of this Action
Requested
Previously Approved
08/31/2015
36 Months From Approved
08/31/2012
168,390
0
175,680
474,873
0
435,360
0
0
0
The purpose of the clinical trials
registry data bank is to enhance patient enrollment and provide a
mechanism to track the progress of clinical trials. The information
is intended to provide current and reliable information on the
broadest possible scale to members of the public, including to
physicians and researchers, about the existence, nature, enrollment
status, location, eligibility criteria, sponsorship and progress of
clinical trials.
Since approval of the previous
OMB Paperwork Reduction Act clearance request, the information
collection has been modified to make mandatory the submission of
adverse event information, consistent with legal requirements of
FDAAA (as it modifies section 282(j)(3)(I) of the PHS Act) that
took effect on September 27, 2009. Submission of such information
was previously voluntary. We have increased the average hourly
burden estimates to reflect this change and to reflect user
feedback regarding results submission times. We have also increased
our estimate of the number of applicable clinical trials that are
subject to the registration requirement of the law to more closely
track recent trends. The result is an increased annual burden
estimated for registration of 39,790 hours above the previous
information collection and an increased estimated annual burden of
16,652.5 hours for the submission of basic results
information.
$4,000,000
No
No
No
No
No
Uncollected
Mikia Currie 3014350941
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form Attachment 3 Drug and Biologic - Mandatory Newly registered Trials
Attachment 2.pdf
Privacy Act review by Karen Pla for NLM Clinical Trials gov Extension.doc
Drug and Biologic - Mandatory Newly registered Trials