REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

ICR 201003-0910-005

OMB: 0910-0836

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-03-11
IC Document Collections
ICR Details
0910-0836 201003-0910-005
Historical Inactive
HHS/FDA
REPORTING INFORMATION REGARDING FALSIFICATION OF DATA
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 10/18/2010
Retrieve Notice of Action (NOA) 03/30/2010
OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects (e.g., clinical investigations) or animal subjects (e.g., nonclinical laboratory studies and clinical studies in animals) conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. The proposed requirement for a sponsor to report information regarding falsification of data would be ongoing and cover the periods before and after study completion, including after the review, approval, or authorization of the affected product or labeling

US Code: 21 USC 301 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
   US Code: 42 USC 201 Name of Law: PHSAct
  
None

0910-AC59 Proposed rulemaking 75 FR 7412 02/19/2010

Yes

1
IC Title Form No. Form Name
REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

Yes
Changing Regulations
No
FDA is amending its regulations to require sponsors to report information indicating the falsification of data in the reporting study results.

$5,475
No
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
03/30/2010


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