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

Forms and Documents

Document Name	Status
ucm079736.pdf Supplementary Document	2011-10-31
SUPPORTING STATEMENT 0910-0389 FINAL 7-29-11.doc Supporting Statement A	2011-07-29

IC Document Collections

IC ID	Document Title	Status
6040	Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Premeeting Packages)	Modified
186322	Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Designation Request)	Modified

ICR Details

OMB Control No: 0910-0389	ICR Reference No: 201108-0910-002
Status: Historical Active	Previous ICR Reference No: 200808-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
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: 02/06/2012
	Date Received in OIRA: 08/01/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved	02/29/2012
Responses	195	0	137
Time Burden (Hours)	14,780	0	10,620
Cost Burden (Dollars)	0	0	0

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Abstract: This guidance is intended to articulate how FDA plans to work with sponsors to facilitate the development and expedite the review of new drugs, including biological products, intended to treat a serious or life-threatening condition and that demonstrate a potential to address an unmet medical need. Under Section 112(b) of Food and Drug Administration Modernization Act of 1997, FDA issued guidance to industry on fast track policies and procedures outlined in Section 506 of the Federal Food, Drug and Cosmetic Act, other sections of the Public Health Service Act, or implementing regulations.

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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:
	76 FR 20679	04/13/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 45261	07/28/2011
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
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Premeeting Packages)
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Designation Request)

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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	195	137	0	0	58	0
Annual Time Burden (Hours)	14,780	10,620	0	0	4,160	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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 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: 08/01/2011

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