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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202008-0910-009 · OMB 0910-0843 · Active

Forms and Documents
DocumentTypeStatusAvailability
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC IDCollectionTypeStatusForm
227561 Guidance Reporting Recommendations Modified
227559 Guidance Recordkeeping Recommendations Modified
ICR Details
0910-0843 202008-0910-009
Active 201707-0910-011
HHS/FDA CDER
GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation
Extension without change of a currently approved collection   No
Regular
Approved without change 09/14/2020
Retrieve Notice of Action (NOA) 08/10/2020
  Inventory as of this Action Requested Previously Approved
09/30/2023 36 Months From Approved 09/30/2020
9,242 0 9,181
134,882 0 123,020
0 0 0
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.
US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None
Not associated with rulemaking
Other Documents for OIRA Review
  84 FR 46742 09/05/2019
85 FR 44902 07/24/2020
No
2
IC Title Form No. Form Name
Guidance Reporting Recommendations
Guidance Recordkeeping Recommendations
  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
No
No
Our estimated burden for the information collection reflects an overall increase corresponding with an increase in submissions to the agency.
$308,543
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/10/2020