OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

ICR 200711-0910-004 · OMB 0910-0459 · Historical Active

Forms and Documents
Document
Name
Status
Supplementary Document
2007-10-10
Supplementary Document
2007-10-10
Supporting Statement A
2008-01-08
IC Document Collections
IC ID
Document
Title
Status
6153 Modified
182781 New
182780 New
182779 New
182778 New
ICR Details
0910-0459 200711-0910-004
Historical Active 200402-0910-005
HHS/FDA
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Revision of a currently approved collection   No
Regular
Approved with change 01/10/2008
Retrieve Notice of Action (NOA) 11/19/2007
Approved as amended by FDA in its revised supporting statement with appropriate changes to the burden accounting.
  Inventory as of this Action Requested Previously Approved
01/31/2011 36 Months From Approved 01/31/2008
43,499 0 38,514
200,839 0 177,165
0 0 0
Sponsors of Investigational New Drug Applications are required, under the Food and Drug Administration Modernization Act, to submit information about clinical trials for serious or life-threatening diseases to a publicly-accessible clinical trials data bank developed by the National Library of Medicine.
US Code: 42 USC 1395y Name of Law: Exclusions from Coverage and Medicare as Secondary Payer
   PL: Pub.L. 105 - 115 113 Name of Law: FDAMA
  
None
Not associated with rulemaking
  72 FR 27140 05/14/2007
72 FR 59295 10/19/2007
No
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 43,499 38,514 0 745 4,240 0
Annual Time Burden (Hours) 200,839 177,165 0 4,172 19,502 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
We believe the previous burden estimate of 177,165 hours per year underestimated the burden. The new estimate of 196,668 hours per year more accurately reflects the burden. The addition of CMS's estimated burden hours has increased the total.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659
  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.
11/19/2007