Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0389 FINAL 12-29-2014.doc Supporting Statement A	2014-12-29

IC Document Collections

IC ID	Document Title	Status
6040	Designation Requests Other-Guidance	Modified
186322	Premeeting Packages Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0389	ICR Reference No: 201412-0910-016
Status: Historical Active	Previous ICR Reference No: 201108-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
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 with change	Conclusion Date: 02/09/2015
	Date Received in OIRA: 12/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	203	0	195
Time Burden (Hours)	15,700	0	14,780
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance describes how FDA plans to work with applicants and sponsors to achieve expedited development and rapid review of new drugs or biological products intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition. A sponsor or applicant seeking to have a drug or biological product designated as one in a fast track drug development program may submit a request for fast track designation as an amendment to an IND or as a supplement to an application. After FDA makes a fast track designation, the sponsor or applicant may submit a pre-meeting package which may include additional information supporting a request to participate in certain fast track programs.

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Authorizing Statute(s): US Code: 21 USC 356 Name of Law: FD&C Act
  

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:
	79 FR 44780	09/30/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 75564	12/18/2014
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
Designation Requests
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	203	195	0	0	8	0
Annual Time Burden (Hours)	15,700	14,780	0	0	920	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 from 14,780 to 15,700 hours is the result of an increase in the number of designation requests and premeeting packages submitted over the past three years.

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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: 12/30/2014

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