Guidance for Industry (GFI): Expedited Programs for Serious Conditions-Drugs and Biologics

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0765 SS for 2017 Extension.pdf	Supporting Statement A	Uploaded 2017-03-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
209911	Promotional Materials for Accelerated Approval Under Section 314.550	Other-Guidance	Removed
209910	Breakthrough Therapy Designation Request	Other-Agency Guidance	Modified
209909	Priority Review Designation Request	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0765	ICR Reference No: 201703-0910-010
Status: Historical Active	Previous ICR Reference No: 201312-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry (GFI): Expedited Programs for Serious Conditions-Drugs and Biologics
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: 05/18/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/15/2017
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	193	0	211
Time Burden (Hours)	10,310	0	19,890
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation. Respondents to the collection are manufacturers or sponsors of drug and/or biologic products.

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Authorizing Statute(s): None

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:
	81 FR 85973	11/29/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 13816	03/15/2017
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Breakthrough Therapy Designation Request
Priority Review Designation Request
Promotional Materials for Accelerated Approval Under Section 314.550

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ICR Summary of Burden

table that charts list 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	193	211	0	0	-18	0
Annual Time Burden (Hours)	10,310	19,890	0	0	-9,580	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:

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Annual Cost to Federal Government: $257,513

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: 03/15/2017

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