[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Notices]
[Page 58316-58317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc07-58]
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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Draft Guidance for Industry on Postmarketing Adverse Event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availability of a draft guidance for industry entitled ``Postmarketing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 This draft guidance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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance,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ADDRESSES: Submit written requests for single copies of the draft
guidance, including comments regarding proposed collection of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comments on the draft guidance to the Division of Dockets Management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
MENTARY
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