The information supports agency
guidance. The guidance describes FDA procedures for sponsors to
request special protocol assessments and for the agency to act on
such requests; to implement section 505(b)(4)(B) of the Federal
Food, Drug, and Cosmetic Act and Prescription Drug User Fee Act
goals for special protocol assessment and agreement. Respondents to
the information collection are sponsors seeking agency action for
regulated products.
PL:
Pub.L. 105 - 115 103 Name of Law: Food and Drug Administration
Modernization Act of 1997
As a result of a decrease in
the number of annual submissions, the agency has lowered its burden
estimate. We have explained the change in our supporting
statement.
$0
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
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.