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

Forms and Documents

Document Name	Status
0389 and 0765 SSA consolidation 2018.pdf Supporting Statement A	2018-02-10

IC Document Collections

IC ID	Document Title	Status
230039	Fast track premeeting packages Other-Agency Guidance	New
230038	Fast track designation request Other-Agency Guidance	New
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: 201802-0910-008
Status: Historical Active	Previous ICR Reference No: 201703-0910-010
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/27/2018
	Date Received in OIRA: 02/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	05/31/2020
Responses	514	0	193
Time Burden (Hours)	34,730	0	10,310
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): US Code: 21 USC 356 Name of Law: FFDCA; Fast track products
  

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:
	82 FR 51846	11/08/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 5428	02/07/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Fast track designation request
Priority Review Designation Request
Breakthrough Therapy Designation Request
Fast track premeeting packages

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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	514	193	0	0	321	0
Annual Time Burden (Hours)	34,730	10,310	0	0	24,420	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: Upon approval of this ICR, OMB Control No. 0910-0389 will be discontinued.

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Annual Cost to Federal Government: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 02/13/2018

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