Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
Guidance for Industry:
Continuous Marketing Applications: Pilot 2 Scientific Feedback and
Interactions During Development of Fast Track Products Under
PDUFA
Extension without change of a currently approved collection
OMB notes that
previous terms of clearance mandated that, "FDA shall revise the
guidance to display the OMB control number, expiration date and the
burden statement." Based on the guidance document submitted as part
of this package, OMB does not find these items displayed. As
expeditiously as possible, FDA is to revise the guidance to comply
with the previous terms of clearance and is to report to OMB when
this is done.
Inventory as of this Action
Requested
Previously Approved
09/30/2010
36 Months From Approved
09/30/2007
8
0
125
640
0
10,000
0
0
0
This guidance discusses how the agency
will implement a pilot program for frequent scientific feedback and
interactions between FDA and applicants during the investigational
phase of certain Fast Track drug and biological products.
Applicants are being asked to apply to participate in the Pilot
program.
US Code:
21
USC 355(a) Name of Law: Federal Food, Drug, and Cosmetic
Act
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:
(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;
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.