The information
collection requirements contained in this proposed rule are not
approved at this time. FDA will resubmit this request at the time
of the final rule, after fully considering public comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
0
0
The proposed rule would amend FDA
regulations concerning the format and content of the "Pregnancy,"
"Labor and Delivery," and "Nursing mothers" subsections of the "Use
in Specific Populations" section of the labeling for human
prescription drugs. The proposal would require that labeling
include a summary of the risks of using a drug during pregnancy and
lactation and a discussion of the data supporting that
summary.
This proposal would require
that labeling include a summary of the risks of using a drug during
pregnancy and latation and a discussion of the data supporting that
summary.
$500,000
No
No
Uncollected
Uncollected
Uncollected
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.