Drug Accountability Record

ICR 200801-0925-002

OMB: 0925-0240

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2008-02-15
IC Document Collections
IC ID
Document
Title
Status
7263 Modified
ICR Details
0925-0240 200801-0925-002
Historical Active 200404-0925-004
HHS/NIH
Drug Accountability Record
Extension without change of a currently approved collection   No
Regular
Approved with change 02/21/2008
Retrieve Notice of Action (NOA) 01/08/2008
Approved consistent with revised supporting statement.
  Inventory as of this Action Requested Previously Approved
02/28/2011 36 Months From Approved 02/29/2008
62,400 0 66,339
6,240 0 3,378
0 0 0

The NCI, as a sponsor of investigational drug trials, has the responsibility to assure to the FDA that systems for drug accountability are being maintained by investigators in its clinical trials program. The data obtained from the drug accountability record is used to track the dispensing of investigational anticancer drugs from receipt from NIC to dispensing or administration to patients. NCI and/or its auditors for compliance reasons use this information.

US Code: 42 USC 413(b)(1) Name of Law: Public Health Service Act
   US Code: 21 USC 312.1; 312.34; 312.53; 312.58 Name of Law: Investigational New Drug Application
  
None

Not associated with rulemaking

  72 FR 45251 08/13/2007
72 FR 61889 11/01/2007
No

1
IC Title Form No. Form Name
Accountability Record 1 DARF

  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 62,400 66,339 0 0 -3,939 0
Annual Time Burden (Hours) 6,240 3,378 0 0 2,862 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$500
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.
01/08/2008


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