Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
Applications for FDA Approval
to Market a New Drug: Patent Listing Requirements and Application
of 30-month Stays on Approval of Abbreviated New Drug Applications
Certifying That...
Extension without change of a currently approved collection
The information collection supports
Form FDA 3542 and 3542a as used by new drug application (NDA)
holders to submit patent declarations as prescribed by agency
regulations. The information collected is required by statue and
used by the agency for listing such information in the "Orange
Book."
US Code:
21
USC 355 Name of Law: THe Federal Food, Drug, and Cosmetic Act;
New Drugs
The information collection
reflects adjustment. Based on fewer submissions we have decreased
our cumulative estimate by 45 annual hours and 2,010
responses.
$0
No
Yes
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.