[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3608-3609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01111]
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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;
Comment Request; 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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the FDA guidance for industry
on ``Postmarketing Adverse Event Reporting for Nonprescription Human
Drug Products Marketed Without an Approved Application.'' This guidance
document provides recommendations on postmarketing serious adverse
event reporting for nonprescription (over-the-counter) human drugs
marketed without an approved application. It provides recommendations
on the minimum data elements that should be included in a serious
adverse event report, the label that should be included with the
report, reporting formats for paper and electronic submissions, and how
and where to submit the reports.
DATES: Submit either electronic or written comments on the collection
of information by March 24, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
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 2 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 2 25,000
(c))..............................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 3609]]
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 5 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 5 100,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Therefore, the estimated annual reporting burden for this
information is 25,000 hours and the estimated annual recordkeeping
burden is 100,000 hours.
Dated: January 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01111 Filed 1-22-15; 8:45 am]
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