Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

ICR 201406-0910-008

OMB: 0910-0771

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-11
ICR Details
0910-0771 201406-0910-008
Historical Active
HHS/FDA CDER
Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 06/19/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved
254 0 0
321 0 0
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The information collection pertains to the submission of periodic safety reports as described in the draft guidance entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report ," which describes the format, content, and timing of a PBRER for an approved drug or biologic. The information collection also pertains to the submission of waiver-related materials as described in the draft guidance entitled "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format," which informs applicants of the conditions under which FDA will exercise its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.

US Code: 21 USC 356,356a,356b,356c,360,371,374 Name of Law: FD&C Act
   US Code: 21 USC 375,379k-l,379aa,and 381 Name of Law: FD&C Act
   US Code: 42 USC 241, 262, and 264 Name of Law: null
   US Code: 21 USC 321,331,351,352,353,355,355a Name of Law: FD&C Act
  
None

Not associated with rulemaking

  78 FR 74151 12/10/2013
79 FR 26766 05/09/2014
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 0 0 254 0 0
Annual Time Burden (Hours) 321 0 0 321 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$375,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
06/19/2014


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