FDA Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develop- ment of Fast Track Products Under PDUFA
ICR 200308-0910-005
OMB: 0910-0518
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0518 can be found here:
FDA Guidance for Industry on
Continuous Marketing Applications: Pilot 2 - Scientific Feedback
and Interactions During Develop- ment of Fast Track Products Under
PDUFA
New
collection (Request for a new OMB Control Number)
This paperwork
is approved on an emergency basis under the following condition:
FDA will revise the guidance document to contain the PRA mandated
disclosure statement including the collection's OMB number,
expiration date and expected burden.
Inventory as of this Action
Requested
Previously Approved
06/30/2004
06/30/2004
125
0
0
10,000
0
0
0
0
0
The 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 development of certain Fast Track drug and biological
products. Applicants are being asked to apply to participate in the
Pilot program.
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.