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

ICR 200212-0910-004

OMB: 0910-0429

Federal Form Document

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ICR Details
0910-0429 200212-0910-004
Historical Active 199910-0910-009
HHS/FDA
Guidance for Industry on Formal Mettings with Sponsors and Applicants for PDUFA Products
Revision of a currently approved collection   No
Regular
Approved without change 02/13/2003
Retrieve Notice of Action (NOA) 12/23/2002
Approved consistent with clarification in FDA memo of 2-9-03.
  Inventory as of this Action Requested Previously Approved
03/31/2006 03/31/2006 02/28/2003
3,103 0 1,985
42,760 0 24,986
0 0 0

The guidance provides information on how the agency will interpret and apply section 119(a) of the Modernization Act, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PUFA products, and provisions of existing regulations describing certain meetings (Secs. 312.47 and 281.82 (21 CFR 312.47 and 312.82)). The gudiance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at Sec. 312.47(b)(1)(ii),...

None
None


No

1
IC Title Form No. Form Name
Guidance for Industry on Formal Mettings with Sponsors and Applicants for PDUFA Products 1571, 1572, 356H

  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 3,103 1,985 0 0 1,118 0
Annual Time Burden (Hours) 42,760 24,986 0 0 17,774 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
12/23/2002


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