NIH will submit
screen shots from each page of the web survey with the main
package. In the interim, the supplemental document that contains
the element definitions provides the detail regarding the questions
that must be completed for each clinical trial. The IC list is
confusing: Although there is only one web-based questionnaire,
there is a separate IC for each component of the burden (devices vs
drugs vs others BY voluntary vs mandatory BY new submissions vs
updating old submissions). Thus, there is an IC for mandatory
device protocols that are new, and a separate IC for voluntary
device protocols that are new, and another one for voluntary device
protocols that are simply adding the new data elements to prior
submissions, etc etc.
Inventory as of this Action
Requested
Previously Approved
01/31/2009
6 Months From Approved
01/31/2011
174,780
0
43,499
433,060
0
200,839
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.
Public Law 110-85 was
enacted on September 27, 2007. The statute modified 42 USC
282(j)(1)(A)(ii) to expand the existing data bank of clinical
trials registry information that was established under previous law
and to make available to the public a searchable data bank of
information about certain controlled clinical trials of drugs,
biologics and devices, as provided for in the statute. The law
mandates the implementation of the revised and expanded clinical
trials registry by December 26, 2007. Since the passage of the law,
staff at the National Library of Medicine has worked with other NIH
officials and representatives of the U.S. Food and Drug
Administration to revise the set of data elements needed to
register an applicable clinical trial in accordance with the law
and to assure smooth transition to the expanded registry. The
imminent statutory deadline requires that clearance of the
information collection mandated by P.L.110-85 be approved and
operational at the earliest possible time. The Director, National
Library of Medicine (NLM), has determined, in accordance with 5 CFR
1320.13, that the collection of the information pursuant to 42 USC
282 (j)(1)(A)(ii)is needed: a) prior to the expiration of time
periods established under 5 CFR 1320; b) is essential to the
mission of the agency; and c) the agency cannot reasonably comply
with the normal clearance procedures because the use of the normal
clearance procedures is reasonably likely to cause a statutory
deadline to be missed.
The program changes reflected
in this request respond to new statutory requirements contained in
Section 801 of Public Law 110-85. The law expands the types of
clinical trials that must be registered in the registration data
bank and increase the number of data elements that must be
submitted. The result is an increased annual burden of
approximately 152,250 hours above the previous information
collection.
$3,000,000
No
No
Uncollected
Uncollected
Uncollected
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.
ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_.pdf
Final NLM.doc
Drug and Biologic - Mandatory