[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53251-53252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se08-76]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 baguilar@omb.eop.gov. 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\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours Per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
Reports of serious adverse 50 250 12,500 2 25,000
drug events (21 U.S.C.
379aa((b) and (c))
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours Per Total Hours
Recordkeepers Recordkeeping Records Record
----------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 200 100 20,000 5 100,000
379aa(e)(1))
----------------------------------------------------------------------------------------------------------------
Total 100,000
----------------------------------------------------------------------------------------------------------------
\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