GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

ICR 201706-0910-017

OMB: 0910-0771

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0771 201706-0910-017
Historical Active 201406-0910-008
HHS/FDA CDER
GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Extension without change of a currently approved collection   No
Regular
Approved without change 11/14/2017
Retrieve Notice of Action (NOA) 08/18/2017
  Inventory as of this Action Requested Previously Approved
11/30/2020 36 Months From Approved 11/30/2017
254 0 254
321 0 321
0 0 0

The information collection pertains to the submission of periodic safety reports as described in the draft guidance entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report ," which describes the format, content, and timing of a PBRER for an approved drug or biologic. The information collection also pertains to the submission of waiver-related materials as described in the draft guidance entitled "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format," which informs applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an ICH E2C(R2) PBRER in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 23578 05/23/2017
82 FR 37098 08/08/2017
No

  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 254 254 0 0 0 0
Annual Time Burden (Hours) 321 321 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$375,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
08/18/2017


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