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
04/30/2012
36 Months From Approved
04/30/2009
175,680
0
174,780
435,360
0
433,060
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. Members of the public, their physicians and health advisors will use the information to identify locations where the clinical trials are conducted. The registry will provide basic information about the trials, their implementation, and how to enroll. Progress of the trials will be updated so that individuals will have current information on initiatives to intervene to treat, cure, ameliorate or prevent the health conditions with which they are afflicted or at risk.
Information will also be collected to distinguish between voluntary and mandatory submissions of information. The Law also requires that the Director of the NIH ensures that the registry data bank is easily used by the public, and that entries are easily compared [PL 110-85, Section 801(a), adding new 42 U.S.C. 282(j)(B)(iv)], making necessary the use of more structured data collection techniques to ensure consistency.
The program changes reflected in this request respond to new statutory requirements contained in Section 801 of Public Law 110-85. For registration information, the law expands the types of clinical trials that must be registered in the registration databank and increase the number of data elements that must be submitted. It also requires the submission of basic results information for trials of products that have been approved or cleared by the FDA. The result is an increased annual burden for registration of approximately 152,250 hours above the previous information collection and an additional annual burden of 39,500 hours for the reporting of basic results information.
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 2 Drug and Biologic - Mandatory
RESPONSES TO QUESTIONS FROM OMB.doc
NLM Response to OMB for Public Comments - 24Mar09.docx
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf
Drug and Biologic - Mandatory