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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
21 USC 356
Name of Law: FD&C Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Designation Requests
Premeeting Packages
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.
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
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
No
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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