Guidance for Industry on Special Protocol Assessment

ICR 201402-0910-003

OMB: 0910-0470

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0470 201402-0910-003
Historical Active 201010-0910-005
HHS/FDA 21437
Guidance for Industry on Special Protocol Assessment
Extension without change of a currently approved collection   No
Approved without change 03/25/2014
Retrieve Notice of Action (NOA) 02/19/2014
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved 03/31/2014
362 0 510
5,080 0 7,244
0 0 0

The guidance describes procedures for sponsors to request special protocol assessment and for the agency to act on such requests, to implement section 505(b)(4)(B) of the act and the Prescription Drug User Fee Act goals for special prtocol assessment and agreement.

PL: Pub.L. 105 - 115 103 Name of Law: Food and Drug Administration Modernization Act of 1997

Not associated with rulemaking

  78 FR 69093 11/18/2013
78 FR 7676 02/10/2014

IC Title Form No. Form Name
Requests for Special Protocol Assessment
Notification for Carcinogenicity Protocols

  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 362 510 0 0 -148 0
Annual Time Burden (Hours) 5,080 7,244 0 0 -2,164 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The adjustment in burden is the result of a decrease in the submissions as described in 12a in the Supporting Statement.

ILa Mizrachi 301 796-7726 [email protected]


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.

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