The Drug Accountability Record (Form NIH 2564) (NCI)

Forms and Documents

Document Name	Status
Form 1 Investigational Agent Accountability Record [aka. Drug Accountability Record Form (DARF)] Form	Modified
Attach 3_Privacy Act Memo.pdf Supplementary Document	2010-09-20
Attach 2_Task Force_DARF.doc Supplementary Document	2010-09-20
Cover memo_DARF.doc Supplementary Document	2010-09-20
SSA_DARF_0925-0240 August.docx Supporting Statement A	2010-09-20

IC Document Collections

IC ID	Document Title	Status
7263	Investigational Agent Accountability Record [aka. Drug Accountability Record Form (DARF)] Form	Modified

ICR Details

OMB Control No: 0925-0240	ICR Reference No: 201010-0925-003
Status: Historical Active	Previous ICR Reference No: 200801-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Drug Accountability Record (Form NIH 2564) (NCI)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/19/2010
	Date Received in OIRA: 10/15/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved	02/28/2011
Responses	67,136	0	62,400
Time Burden (Hours)	6,714	0	6,240
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 413(b)(1) Name of Law: Public Health Service Act
   US Code: 21 USC 312.64 Name of Law: Food and Drugs
   US Code: 21 USC 312.62 Name of Law: Food and Drugs
   US Code: 21 USC 312.68 Name of Law: Food and Drugs
   US Code: 21 USC 312.57 Name of Law: Food and Drugs
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 46945	08/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 61763	10/06/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Investigational Agent Accountability Record [aka. Drug Accountability Record Form (DARF)]	1	Drug Accountability Record Form (DARF)

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ICR Summary of Burden

	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	67,136	62,400	0	0	4,736	0
Annual Time Burden (Hours)	6,714	6,240	0	0	474	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $17,500

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/15/2010

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