Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

ICR 201510-0910-004

OMB: 0910-0429

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-10-19
IC Document Collections
ICR Details
0910-0429 201510-0910-004
Historical Active 201207-0910-007
HHS/FDA CDER
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Extension without change of a currently approved collection   No
Regular
Approved without change 12/31/2015
Retrieve Notice of Action (NOA) 10/21/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
4,728 0 3,864
64,088 0 51,416
0 0 0

The guidance describes the procedures for requesting, scheduling, conducting, and documenting formal meetings with applicants and sponsors, including the submission of a meeting request and the submission of an information package in advance of the formal meeting.

US Code: 21 USC 312 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 29010 05/20/2015
80 FR 60913 10/08/2015
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 4,728 3,864 0 0 864 0
Annual Time Burden (Hours) 64,088 51,416 0 0 12,672 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted the approved burden of 51,416 hours based on actual submissions received under the guidance during the past 3 years. The new burden is 63,992 hours.

$0
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.
10/21/2015


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