GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

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

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
227561	Guidance Reporting Recommendations		Modified
227559	Guidance Recordkeeping Recommendations		Modified

ICR Details

OMB Control No: 0910-0843	ICR Reference No: 202008-0910-009
Status: Active	Previous ICR Reference No: 201707-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation
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: 09/14/2020
	Date Received in OIRA: 08/10/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2023	36 Months From Approved	09/30/2020
Responses	9,242	0	9,181
Time Burden (Hours)	134,882	0	123,020
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports agency guidance. The guidance recommends that sponsors develop and implement a quality management system throughout all stages of the clinical trial process. The guidance also recommends that sponsors describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report.

---

Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46742	09/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 44902	07/24/2020
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Guidance Reporting Recommendations
Guidance Recordkeeping Recommendations

---

ICR Summary of Burden

table that charts list 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	9,242	9,181	0	0	61	0
Annual Time Burden (Hours)	134,882	123,020	0	0	11,862	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 corresponding with an increase in submissions to the agency.

---

Annual Cost to Federal Government: $308,543

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? 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: 08/10/2020

---