[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36543-36545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0915]
Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; Guidance for
Industry on Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
27, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_
[[Page 36544]]
[email protected]. All comments should be identified with the OMB
control number 0910-0636. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application (OMB Control Number 0910-0636)--Extension
Respondents to this collection of information are manufacturers,
packers, and distributors whose name (under section 502(b)(1) (21
U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act)) appears on the label of a nonprescription drug marketed in the
United States. FDA is requesting public comment on estimates of annual
submissions from these respondents, as required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L.
109-462) and described in the guidance. The guidance document discusses
what should be included in a serious adverse drug event report
submitted under section 760(b)(1) (21 U.S.C. 379aa(b)(1)) of the FD&C
Act, including follow-up reports under 760(c)(2) (21 U.S.C.
379aa(c)(2)) of the FD&C Act, and how to submit these reports. The
estimates for the annual reporting and recordkeeping burdens are based
on FDA data on the number of adverse drug experience reports submitted
for nonprescription drug products marketed without an approved
application, including FDA's knowledge about the time needed to prepare
the reports and to maintain records.
In the Federal Register of January 23, 2015 (80 FR 3608), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. The comment
requested that we increase the reporting burden estimates from 2 hours
to 6 hours and the recordkeeping burden estimates from 5 hours to 8
hours. The comment said although there may be circumstances where FDA's
estimates for reporting and recordkeeping may be accurate, the comment
contended that, in its experience, the approximations are
underestimated. The comment said that as many as 6 hours may be
required to complete a single serious adverse event report, especially
when the sponsor's medical and quality review teams are involved, and
that as many as 8 hours may be required to maintain all relevant
records for a single adverse event report as stipulated by statute.
FDA Response: We have reconsidered our estimates, and agree with
the comment that there may be circumstances where 6 hours would be
needed to prepare and submit a report to us and 8 hours may be needed
for recordkeeping. We have revised our reporting and recordkeeping
burden estimates accordingly.
Based on FDA data, we estimate between 10,000 and 15,000 (i.e.,
approximately 12,500) total annual responses from approximately 50
respondents for nonprescription drugs marketed without an approved
application, and we also estimate that each submission will take
approximately 6 hours to prepare and submit.
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Reports of serious adverse drug events (21 U.S.C. 379aa((b) and 50 250 12,500 6 75,000
(c))..............................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance document recommends that respondents maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any follow-up reports. We estimate
that there are approximately 20,000 records per year maintained by
approximately 200 respondents, and that it takes approximately 8 hours
to maintain each record.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping (21 U.S.C. 379aa(e)(1)).............................. 200 100 20,000 8 160,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 36545]]
Therefore, the estimated annual reporting burden for this
information is 25,000 hours and the estimated annual recordkeeping
burden is 100,000 hours.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15638 Filed 6-24-15; 8:45 am]
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