[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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