Formal Meetings with Sponsors and Applicants for PDUFA Products

ICR 202002-0910-002

OMB: 0910-0429

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6097
Modified
189764
Modified
189763
Modified
189762
Modified
ICR Details
0910-0429 202002-0910-002
Active 201510-0910-004
HHS/FDA CDER
Formal Meetings with Sponsors and Applicants for PDUFA Products
Reinstatement with change of a previously approved collection   No
Regular
Approved with change 05/04/2020
Retrieve Notice of Action (NOA) 02/13/2020
  Inventory as of this Action Requested Previously Approved
05/31/2023 36 Months From Approved
6,153 0 0
83,386 0 0
0 0 0

This information collection supplements FDA regulations by providing recommendations to industry on what to include in formal meeting requests between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by FDA.

US Code: 21 USC 360bbb Name of Law: FFDCA; General Provisions Relating to Drugs
  
PL: Pub.L. 115 - 52 601-611 Name of Law: FDARA of 2017; Improvements Related to Drugs

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 13130 07/11/2018
84 FR 71430 12/27/2019
No

4
IC Title Form No. Form Name
CDER - Meeting Requests
CBER- Meeting Requests
CDER - Information Packages
CBER - Information Packages

  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 6,153 0 0 0 6,153 0
Annual Time Burden (Hours) 83,386 0 0 0 83,386 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection is being reinstated with change. We have revised the guidance document to include relevant discussion of updated performance goals under the FDARA of 2017. Although it currently remains a draft, we ultimately intend to finalize the guidance. We have also made adjustments to the annual burden hours and responses, which reflect an increase of 83,386 and 6,153 respectively. We attribute the adjustment to an increase in meeting requests and packages associated with our PDUFA program.

$0
No
    Yes
    No
No
No
No
Uncollected
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.
02/13/2020


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