Guidance for Industry (GFI): Special Protocol Assessment

ICR 201703-0910-006

OMB: 0910-0470

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-03-15
ICR Details
0910-0470 201703-0910-006
Historical Active 201402-0910-003
HHS/FDA CDER
Guidance for Industry (GFI): Special Protocol Assessment
Extension without change of a currently approved collection   No
Regular
Approved without change 05/18/2017
Retrieve Notice of Action (NOA) 03/15/2017
  Inventory as of this Action Requested Previously Approved
05/31/2020 36 Months From Approved 05/31/2017
273 0 362
3,724 0 5,080
0 0 0

The information supports agency guidance. The guidance describes FDA procedures for sponsors to request special protocol assessments and for the agency to act on such requests; to implement section 505(b)(4)(B) of the Federal Food, Drug, and Cosmetic Act and Prescription Drug User Fee Act goals for special protocol assessment and agreement. Respondents to the information collection are sponsors seeking agency action for regulated products.

PL: Pub.L. 105 - 115 103 Name of Law: Food and Drug Administration Modernization Act of 1997
  
None

Not associated with rulemaking

  81 FR 81776 11/18/2016
82 FR 13820 03/15/2017
No

2
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 273 362 0 0 -89 0
Annual Time Burden (Hours) 3,724 5,080 0 0 -1,356 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
As a result of a decrease in the number of annual submissions, the agency has lowered its burden estimate. We have explained the change in our supporting statement.

$0
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
03/15/2017


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