Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
204492	Development of Comprehensive Monitoring Plan		Modified

ICR Details

OMB Control No: 0910-0733	ICR Reference No: 201903-0910-023
Status: Active	Previous ICR Reference No: 201512-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
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: 07/18/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2019
Responses	132	0	132
Time Burden (Hours)	528	0	528
Cost Burden (Dollars)	39,600	0	0

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Abstract: This information collection supports FDA guidance. Regulations pertaining to investigational new drug applications (21 CFR part 312, currently approved under OMB Control No. 0910-0014) provide for the monitoring of ongoing clinical investigations (see 21 CFR 312.56). To assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof, we developed this agency guidance.

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Authorizing Statute(s): US Code: 21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and Cosmetic Act
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 61646	11/30/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 15620	04/16/2019
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
Development of Comprehensive Monitoring Plan

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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	132	132	0	0	0	0
Annual Time Burden (Hours)	528	528	0	0	0	0
Annual Cost Burden (Dollars)	39,600	0	0	0	39,600	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: $0

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.     No

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? 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: 06/26/2019

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