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_2022.docx Supporting Statement A	2022-03-29

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: 202110-0910-010
Status: Received in OIRA	Previous ICR Reference No: 201901-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
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	Date Submitted to OIRA: 03/31/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2022
Responses	14,584	10,099
Time Burden (Hours)	3,478	3,180
Cost Burden (Dollars)	0	0

---

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.

---

Authorizing Statute(s): US Code: 21 USC 54 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 68500	12/02/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 18371	03/30/2022
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
54.4(b)--Clinical Investigators Third Party Disclosure
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
Recordkeeping--54.6

---

ICR Summary of Burden

	Total Request	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	14,584	10,099	0	0	4,485	0
Annual Time Burden (Hours)	3,478	3,180	0	0	298	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: Our estimated burden for the information collection reflects an overall increase of 298 hours and a corresponding increase of 4,485 responses/records. We attribute this adjustment to an increase in the number of affected applications and the number of investigators. The estimated number of respondents has decreased from 1,050 to 715 for Certification, from 105 to 72 for Disclosure, and from 1,050 to 715 for Recordkeeping due to a decrease in the estimated number of affected applications. The estimated number of respondents for third-party disclosure has increased from 7,894 to 13,082 due to adjustments in the number of affected applications and the number of investigators. No program changes were made. Upon review, we have corrected an inadvertent omission with regard to the number of biologics license applications (BLAs) and BLA efficacy supplements received by our Center for Drug Evaluation and Research (CDER) and used, in part, as a basis for calculating the cumulative burden estimate.

---

Annual Cost to Federal Government: $211,819

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

---

Common Form ICR:  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:

(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: 03/31/2022

---