Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)

Forms and Documents

Document Name	Status
Form 3 Financial Disclosure Form Form and Instruction	Modified
Form 2 Supplemental Investigator Data Form Form and Instruction	Modified
Form 1 Statement of Investigator (Modified FDA Form 1572) Form and Instruction	Modified
Public comment & response.pdf Supplementary Document	2009-12-15
Attachment 5_OHSR not needed.pdf Supplementary Document	2009-12-15
Attachment 4_Privacy Act Memo_InvestRegis.doc Supplementary Document	2009-12-15
Cover Memo Investigator Registration.doc Supplementary Document	2009-12-15
SSA_Investigator Registration_12-15-09.doc Supporting Statement A	2009-12-15

IC Document Collections

IC ID	Document Title	Status
190377	Financial Disclosure Form Form and Instruction	Modified
190376	Supplemental Investigator Data Form Form and Instruction	Modified
190375	Statement of Investigator (Modified FDA Form 1572) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0613	ICR Reference No: 201001-0925-002
Status: Historical Active	Previous ICR Reference No: 200909-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/18/2010
	Date Received in OIRA: 01/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved
Responses	51,384	0	0
Time Burden (Hours)	8,564	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The FDA holds the NCI responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer.

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Authorizing Statute(s): US Code: 21 USC 312.50 Name of Law: null
   US Code: 21 USC 312.53 Name of Law: null
   US Code: 21 USC 312.55 Name of Law: null
  

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:
	74 FR 27552	06/10/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 68065	12/22/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Statement of Investigator (Modified FDA Form 1572)	1	Statement of Investigator
Supplemental Investigator Data Form	2	Supplemental Investigator Data Form
Financial Disclosure Form	3	Financial Disclosure Form

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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	51,384	0	0	0	0	51,384
Annual Time Burden (Hours)	8,564	0	0	0	0	8,564
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: $795,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/27/2010

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