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. 0910Â0291, 0910Â0230, 0910Â0308, and 0910Â0636). (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 0910Â0291, 0910Â0230, 0910Â0308, and/or 0910Â0636 (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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
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0
0
0
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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.
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No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482
Reginfo record details
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