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

ICR 201207-0910-007

OMB: 0910-0429

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-07-20
IC Document Collections
IC ID
Document
Title
Status
6097
Modified
189764
Modified
189763
Modified
189762
Modified
ICR Details
0910-0429 201207-0910-007
Historical Active 200906-0910-004
HHS/FDA
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Revision of a currently approved collection   No
Regular
Approved without change 12/27/2012
Retrieve Notice of Action (NOA) 07/20/2012
OMB notes that this was an "Extension without change," and not a revision.
  Inventory as of this Action Requested Previously Approved
12/31/2015 36 Months From Approved 12/31/2012
3,864 0 4,401
51,416 0 59,234
0 0 0

This collection of information describes procedures for requesting, scheduling, conducting, and documenting formal meetings.

US Code: 21 USC 312 Name of Law: FFDCA
  
None

Not associated with rulemaking

  77 FR 16235 03/20/2012
77 FR 42744 07/20/2012
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 3,864 4,401 0 0 -537 0
Annual Time Burden (Hours) 51,416 59,234 0 0 -7,818 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 [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.
07/20/2012


© 2021 OMB.report | Privacy Policy