[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58316-58317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5073]



[[Page 58316]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0386]


Draft Guidance for Industry on Postmarketing Adverse Event 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availability of a draft guidance for industry entitled ``Postmarketing 
Adverse Event Reporting for Nonprescription Human Drug Products 
Marketed Without an Approved Application.'' This draft guidance 
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 the Center 
for Food Safety and Applied Nutrition on reporting for dietary 
supplements, is announced elsewhere in this issue of the Federal 
Register.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance, 
including comments regarding proposed collection of information, by 
December 14, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance, including comments regarding proposed collection of 
information, to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the draft guidance to the Division of Dockets Management 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.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft 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 draft 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, which was signed by the President on December 22, 2006, 
states: ``Not later than 270 days after the date of enactment of this 
Act, the Secretary of Health and Human Services shall issue guidance on 
the minimum data elements that should be included in a serious adverse 
event report as described under the amendments made by this Act'' 
(section 2(e)(3)). Public Law 109-462 also requires certain 
postmarketing safety reports for dietary supplements.
    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). 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. 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 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.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 
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 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 below.
    With respect to the following collection of information, FDA 
invites comment on: (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

[[Page 58317]]

burden of the collection on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Postmarketing Adverse Event Reporting and Recordkeeping for 
Nonprescription Human Drug Products Marketed Without an Approved 
Application as Required by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors whose name 
(pursuant to section 502(b)(1) of the act) appears on the label of a 
nonprescription drug marketed in the United States.
    Burden Estimate: FDA is requesting public comment on estimates of 
annual submissions from these respondents, expected in 2008, as 
required by Public Law 109-462 and described in this guidance. This 
guidance document discusses what should be included in a serious 
adverse drug event report submitted under section 760(b)(1) of the act, 
including follow-up reports under 760(c)(2) of the 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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                                                              No. of         Annual frequency       Total annual        Hours per
                                                           respondents         per response          responses           response         Total hours
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Reports of serious adverse drug events (21 U.S.C.                      50                   250             12,500                  2             25,000
 379aa((b) and (c))
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Total                                                                                                                                             25,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 760(e) of the 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 draft 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 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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                                                              No. of         Annual frequency       Total annual
                                                          recordkeepers      per recordkeeping        records       Hours per  record     Total hours
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Recordkeeping (21 U.S.C. 379aa(e)(1))                                 200                   100             20,000                  5            100,000
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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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5073 Filed 10-11-07; 11:34 am]
BILLING CODE 4160-01-S