This information
collection request is approved as revised. Note that the burden
tables were changed to be consistent with what was reported in the
supporting statement and to reflect that the burden changes were
due to adjustment, consistent with submission as "extension without
change." Approval is consistent with the understanding that burden
is decreasing due to the fact that submissions of certain types of
information are no longer required by regulation (i.e. the final
rule required the information to be submitted within 3 years from
the effective date of the rule and those 3 years have passed). In
the future, FDA should provide more fulsome explanation in the
supporting statement when burden or cost is changing and ensure
that the burden and cost estimates match up with the estimates
provided in the supporting statement.
Inventory as of this Action
Requested
Previously Approved
04/30/2012
36 Months From Approved
04/30/2009
973
0
1,911
471,295
0
501,383
0
0
0
The final rule would revise the
requirements governing the content and format of labeling for human
prescription drug products. The final rule is part of FDA's risk
management strategic initiative. The revisions will make it easier
for health care practitioners to access, read, and use information
in prescription drug labeling, and is an essential step forward
towards the success of the agency's electronic labeling initiative.
Respondents include persons, businesses, including small business
and manufacturers.
The changes in burden from the
information collection in the final rule are the result of
reductions in the number of submissions that have occurred because
3 years have expired under the implementation plan.
$1,946,000
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.
0572 SS 2008doc 2.doc
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule