[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53251-53252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0434] (formerly Docket No. 2007D-0386)


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 October 
15, 2008.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-NEW and title 
``Guidance for Industry on Postmarketing Adverse Event Reporting for 
Nonprescription Human Drug Products Marketed Without an Approved 
Application.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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

    Public Law 109-462, the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act, amended the Federal Food, Drug, and Cosmetic 
Act (the act) to add safety reporting requirements for nonprescription 
drug products that are marketed without an approved application. In 
accordance with section 760(b) of the act (21 U.S.C. 379aa), the 
manufacturer, packer, or distributor whose name appears on the label of 
a nonprescription drug marketed in the United States without an 
approved application (referred to as the responsible person) must 
submit to FDA any report of a serious adverse event associated with 
such drug when used in the United States, accompanied by a copy of the 
label on or within the retail package of such drug. In addition, the 
responsible person must submit followup reports of new medical 
information related to a submitted serious adverse event report that is 
received within 1 year of the initial report (section 760(c)(2) of the 
act). Section 760(e) of the act also requires that responsible persons 
maintain records of nonprescription drug adverse event reports, whether 
or not the event is serious, for a period of 6 years. The guidance 
document provides information on: (1) The minimum data elements that 
should be included in a serious adverse event report, (2) the label 
that should be included with the report, (3) reporting formats for 
paper and electronic submissions, and (4) how and where to submit the 
reports.
    Title: Guidance for Industry on Postmarketing Adverse Event 
Reporting for Nonprescription Human Drug Products Marketed Without an 
Approved Application.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, or distributors whose name 
appears on the label of a nonprescription drug marketed in the United 
States without an approved application.
    Burden Estimate: FDA is requesting public comment on estimates of 
the number of annual submissions from these respondents and 
recordkeeping, as required by Public Law 109-462 and described in the 
guidance ``Postmarketing Adverse Event Reporting for Nonprescription 
Human Drug Products Marketed Without an Approved Application.'' The 
estimates for annual reporting and recordkeeping are based on FDA's 
knowledge of adverse drug experience reports historically submitted 
annually 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 data, we estimate between 10,000 and 15,000 
(i.e., 12,500) total annual responses from approximately 50 respondents 
for nonprescription drugs marketed without an approved application, and 
that each submission will take approximately 2 hours to prepare and 
submit to FDA.
    In the Federal Register of October 15, 2007 (72 FR 58316), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 53252]]



                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                   Annual
                                  No. of       Frequency per     Total Annual      Hours Per       Total Hours
                               Respondents        Response        Responses         Response
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Reports of serious adverse                50              250           12,500                2           25,000
 drug events (21 U.S.C.
 379aa((b) and (c))
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Total                                                                                                     25,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The guidance also 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 document does not provide recommendations on all the 
recordkeeping activities required under section 760(e) of the act, we 
are providing an estimate for this burden. 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, we estimate the total annual records to be 
approximately 20,000 records per year, and the number of respondents to 
be approximately 200. We also estimate that it takes approximately 5 
hours to maintain each record.

                               Table 2.-- Estimated Annual Recordkeeping Burden\1\
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                                                   Annual
                                  No. of       Frequency per     Total Annual      Hours Per       Total Hours
                              Recordkeepers    Recordkeeping       Records           Record
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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 collection is 25,000 hours and the estimated annual 
recordkeeping burden is 100,000 hours.

    Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21345 Filed 9-12-08; 8:45 am]
BILLING CODE 4160-01-S