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.
table that charts list comparision
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
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