The PDUFA of 1992 as amended by FDAMA
1997 and the PHS and Bioterrorism Preparedness and Response Act of
2002 which includes the Prescription Drug User Fee Amendments of
2002 reauthorizes the assessment and use of fees relating to human
drugs and licensed biologic products. Form FDA 3397 is used to
account for and track user fees reauthorized by PDUFA 1992/FDAMA
1997/FDUFA 2002. The form requests the minimum information
necessary to determine whether a fee is required for review of
human drug or licensed biologic product applications and
supplements. Respodents are manufacturers of human drug and
licensed biologic products.
US Code:
21
USC 379 Name of Law: Federal Food Drug and Cosmetic Act
The estimated total annual
burden for this information collection requirement was 1,128 hours
in 2006. The current increase to 1,959 burden hours is attributed
to the increase in the hours per response from 0.3 hours to 0.5
hours. The hours per response were revised for consistency with
theh OMB statement on the form. The total annual responses slightly
in creased from 3,761 in FY 2005 to 3,917 in FY 2008.
$180,182
No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos
3018271482
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:
(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.