Guidance for Industry on Special Protocol Assessment

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 2-12-14.doc Supporting Statement A	2014-02-12

IC Document Collections

IC ID	Document Title	Status
6167	Requests for Special Protocol Assessment Other-Guidance	Modified
181848	Notification for Carcinogenicity Protocols Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0470	ICR Reference No: 201402-0910-003
Status: Historical Active	Previous ICR Reference No: 201010-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: 21437
Title: Guidance for Industry on Special Protocol Assessment
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/25/2014
	Date Received in OIRA: 02/19/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	36 Months From Approved	03/31/2014
Responses	362	0	510
Time Burden (Hours)	5,080	0	7,244
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 105 - 115 103 Name of Law: Food and Drug Administration Modernization Act of 1997
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 69093	11/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 7676	02/10/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The adjustment in burden is the result of a decrease in the submissions as described in 12a in the Supporting Statement.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 02/19/2014

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