[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80946-80947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33140]
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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 February 27, 2012.
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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.
PI50-400B, Rockville, MD 20850, (301) 796-7651,
[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
[[Page 80947]]
section 502(b)(1) (21 U.S.C. 352(b)(1)) of the Federal Food, Drug, and
Cosmetic Act (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 (Public Law 109-462) and
described in the guidance. This 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
followup 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 annual
reporting burden and recordkeeping are based on FDA's knowledge of
adverse drug experience reports historically submitted per year for
prescription drug products and for nonprescription drug products
marketed under an approved application, including knowledge about the
time needed to prepare the reports and to maintain records.
FDA receives approximately 2,500 serious adverse event reports for
nonprescription drug products marketed under approved applications,
which comprise approximately 20 percent of the overall nonprescription
drug market. Based on this experience, we estimate between 10,000 and
15,000 (i.e., 12,500) total annual responses for nonprescription drugs
marketed without an approved application.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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Reports of Serious Adverse Drug 50 250 12,500 2 25,000
Events (21 U.S.C. 379aa(b) and
(c))...........................
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Total....................... .............. .............. .............. .............. 25,000
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[sup1] 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 recommends that responsible persons maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any followup reports. Although the
guidance does not provide recommendations on recordkeeping activities
generally under section 760(e) of the FD&C Act, FDA is providing an
estimate for the burden of this collection. Historically, serious
adverse event reports comprise approximately two-thirds and nonserious
adverse event reports comprise approximately one-third of the total
number of postmarketing adverse event reports associated with drugs and
biologic therapeutics (except vaccines) received by FDA. Based on this
generalization, FDA estimates the total annual records to be
approximately 20,000 records per year. FDA estimates that it takes 5
hours to maintain each record and the recordkeeping burden as follows:
Table 2--Estimated Annual Recordkeeping Burden \1\
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Average burden
Number of Number of Total annual per
Activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
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Recordkeeping (21 U.S.C. 200 100 20,000 5 100,000
379aa(e)(1))...................
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Total....................... .............. .............. .............. .............. 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: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33140 Filed 12-23-11; 8:45 am]
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