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
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