Financial Disclosure by Clinical Investigators

Forms and Documents

Document Name	Status
Form 3454 Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form	Modified
Form 3455 Disclosure--54.4(a)(3)--Form FDA 3455 Form	Modified
0396--supporting statement.doc Supporting Statement A	2015-10-06

IC Document Collections

IC ID	Document Title	Status
6057	Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form	Modified
188973	Recordkeeping--54.6	Modified
188972	54.4(b)--Clinical Investigators Third Party Disclosure	Modified
188971	Disclosure--54.4(a)(3)--Form FDA 3455 Form	Modified

ICR Details

OMB Control No: 0910-0396	ICR Reference No: 201510-0910-002
Status: Historical Active	Previous ICR Reference No: 201207-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Financial Disclosure by Clinical Investigators
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 with change	Conclusion Date: 03/22/2016
	Date Received in OIRA: 11/06/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	03/31/2016
Responses	9,206	0	12,448
Time Burden (Hours)	2,958	0	3,372
Cost Burden (Dollars)	0	0	0

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Abstract: The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

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Authorizing Statute(s): US Code: 21 USC 54.4 Name of Law: FFDCA
   US Code: 21 USC 54.1 Name of Law: FFDCA
   US Code: 21 USC 54.6 Name of Law: FFDCA
  

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:
	80 FR 23803	04/29/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 66542	10/29/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Certification--54.4(a)(1) and (a)(2)--Form FDA 3454	3454	FDA Form 3454
Disclosure--54.4(a)(3)--Form FDA 3455	3455	FDA Form 3455
54.4(b)--Clinical Investigators Third Party Disclosure
Recordkeeping--54.6

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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	9,206	12,448	0	0	-3,242	0
Annual Time Burden (Hours)	2,958	3,372	0	0	-414	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: The estimated number of respondents has increased from 902 to 1,000 for Certification, from 90 to 100 for Disclosure, and from 902 to 1,000 for Recordkeeping due to an increase in the estimated number of affected applications. The estimated number of respondents for third-party disclosure has decreased from 10,554 to 7,106. The sum of these adjustments has resulted in a 414-hour decrease of the total hour burden. No program changes were made.

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Annual Cost to Federal Government: $124,454

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: 11/06/2015

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