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.
table that charts list comparision
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
Reginfo record details
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.
Drug and Biologic - Mandatory Newly registered Trials