[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34023-34024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16738]


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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)]


Guidance for Industry on Postmarketing Adverse Event Reporting 
for Nonprescription Human Drug Products Marketed Without an Approved 
Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Postmarketing 
Adverse Event Reporting for Nonprescription Human Drug Products 
Marketed Without an Approved Application.'' This document provides 
guidance to industry on postmarketing serious adverse event reporting 
for nonprescription (over-the-counter (OTC)) human drugs marketed 
without an approved application. It gives guidance 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. Separate guidance, issued by FDA's Center for Food Safety and 
Applied Nutrition on adverse event reporting for dietary supplements, 
is announced elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kathleen Frost, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4312, Silver Spring, MD 20993-0002, 301-
796-2380.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``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, enacted on December 22, 2006, required FDA to issue 
guidance on the minimum data elements that should be included in a 
serious adverse

[[Page 34024]]

event report (section 2(e)(3)). The guidance document provides 
information on the following topics: (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.
    Public Law 109-462 amends 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). Public Law 109-462 also requires certain postmarketing safety 
report!s for dietary supplements.
    In the Federal Register of October 15, 2007 (72 FR 58316), FDA 
announced the availability of a draft guidance of the same title. FDA 
received several comments on the draft guidance and considered those 
comments when finalizing the guidance. The guidance announced in this 
notice finalizes the draft guidance dated October 2007.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on postmarketing adverse event reporting for 
nonprescription human drug products marketed without an approved 
application. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
OMB Control No. 0910-0636.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16738 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S