OMB is filing
comment on this ICR which is associated with a proposed rule.
Approval is not granted at this time. FDA should resubmit this ICR
in conjunction with the final rule. Upon resubmission, FDA shall
correct the following: (1) these burdens should be classified as
"change due to agency discretion" and not "change due to statute";
(2) provide a unique title for each IC (the current submission uses
the same title for each IC); (3) as the ICs in this ICR pertain to
reporting requirements for respondents seeking waivers, and as the
regulation stated that the waivers do not impose any capital costs,
FDA should clarify whether this ICR actually imposes $884 in annual
cost burden; (4) if this ICR does impose capital costs, FDA should
ensure that these are discussed in #13 of the supporting statement
and that the capital costs noted there reflect what is submitted in
ICRAS/ROCIS; (5) FDA shall correct the supporting statement to
ensure that it discusses the burden imposed by the waiver
requirements only (whereas the supporting statement currently
discussed all burden and costs, even those accounted for in other
OMB control numbers). (6) The proposed rule estimated that the
conversion from paper to electronic reporting would incur $4.5
million - $5.6 million one-time costs (for changing SOPs, setting
up systems for submissions, and acquiring an electronic
certificate) and further annual costs of $133,320 - $139,380 for
Internet upgrades and to maintain electronic certificates. As
agreed, FDA shall immediately ascertain which ICRs to allocate
these capital costs to from among the OMB control numbers
referenced in this rule (i.e. 09100291, 09100230, 09100308, and
09100636). (7) The conversion to electronic submission is
considered a substantive change and, in this case, carries a
significant cost burden. Therefore, FDA should immediately submit
ICR Revisions to 09100291, 09100230, 09100308, and/or 09100636
(as appropriate) to capture this capital cost burden. (8) FDA is
reminded that ICRs associated with proposed rules should be
submitted at the same time that the proposed rule is published or
shortly thereafter. At the final rule stage, ICRs without these
changes will be considered improperly submitted. (9) Finally, FDA
is reminded to include the Federal Register citations and
publication date information for rules in ICRAS/ROCIS for ICRs
associated with proposed rules.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
0
0
FDA is proposing to require that all
postmarketing safety reports for human drugs and biological
products be submitted in electronic format. By requiring submission
of these reports in electronic format, FDA would expedite access to
safety information and facilitate international harmonization and
exchange of this information. This, in turn, would lead to more
efficient reviews of safety data and enhance our ability to rapidly
disseminate safety information to health care providers, consumers,
applicants, sponsors, and other regulatory authorities in support
of FDA's public health mission. In addition, the agency would
recognize a significant cost savings by converting the safety
reporting system from a paper submission process to an all
electronic system that would increase the accuracy of information
and reduce the need for manual data entry.
This is a new collection of
information that identifies the requirement of an electronic format
for the submission of postmarketing safety reports.
$0
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.
ESADRpr SSfinal 9 2009.doc
Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements