Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices

Forms and Documents

Document Name	Status
0741_Supporting Statement.doc Supporting Statement A	2018-03-14

IC Document Collections

IC ID	Document Title	Status
206693	Reporting and Recordkeeping	Modified

ICR Details

OMB Control No: 0910-0741	ICR Reference No: 201803-0910-006
Status: Active	Previous ICR Reference No: 201304-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/15/2018
	Date Received in OIRA: 03/15/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved
Responses	2,010	0	0
Time Burden (Hours)	17,780	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The information collection updates the standards for FDA acceptance of data from clinical investigations conducted outside the United States and helps ensure the protection of human subjects and the quality and integrity of data obtained from these investigations. We are also amending the investigational device exemption (IDE) and premarket notification (510(k)) regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. The information collection includes additional maintenance, retention, and submission of documents indicating (1) clinical investigations conducted outside the United States and used to support IDE or device marketing applications or submissions are conducted in accordance with good clinical practice (GCP), and (2) availability of data for FDA inspection, if deemed necessary. The information allows reviewers to assess the appropriateness and adequacy of the clinical investigation design, data collection plans, conduct, and performance, and helps to protect human subjects participating in medical device clinical investigations.

---

Authorizing Statute(s): US Code: 21 USC 360j Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG48	Final or interim final rulemaking	83 FR 7366	02/21/2018

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Reporting and Recordkeeping

---

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	2,010	0	0	0	2,010	0
Annual Time Burden (Hours)	17,780	0	0	0	17,780	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: NEW

---

Annual Cost to Federal Government: $110,902

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

---

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: 03/15/2018

---