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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:
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
Retrieve Notice of Action (NOA)
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
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.
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:
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
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 (Designation Request)
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (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
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.
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:
Eliazabeth Berbakos 3018271482
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:
08/01/2011
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