[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76358-76360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29664]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0633]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Drug Experience Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on postmarketing adverse drug
experience reporting and recordkeeping requirements.
DATES: Submit written or electronic comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets
[[Page 76359]]
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the 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: Under the PRA (44 U.S.C. 3501-3520), 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, including
each proposed extension of an existing 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 in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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 burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and
314.80 (OMB Control Number 0910-0230)--Extension
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that
marketed drugs be safe and effective. In order to know whether drugs
that are not safe and effective are on the market, FDA must be promptly
informed of adverse experiences occasioned by the use of marketed
drugs. In order to help ensure this, FDA issued regulations at
Sec. Sec. 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose
reporting and recordkeeping requirements on the drug industry that
would enable FDA to take the action necessary to protect the public
health from adverse drug experiences.
All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences, as well as followup reports when needed (Sec.
314.80(c)(1)). This includes reports of all foreign or domestic adverse
experiences as well as those based on information from applicable
scientific literature and certain reports from postmarketing studies.
Section 314.80(c)(1)(iii) pertains to such reports submitted by non-
applicants. Under Sec. 314.80(c)(2), applicants must provide periodic
reports of adverse drug experiences. A periodic report includes, for
the reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences and a history of actions taken because of adverse drug
experiences. Under Sec. 314.80(i), applicants must keep records of all
adverse drug experience reports known to the applicant for 10 years.
For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as followup reports when
needed (Sec. 310.305(c)). Section 310.305(c)(5) pertains to the
submission of followup reports to reports forwarded by FDA. Under Sec.
310.305(f), each manufacturer, packer, and distributor shall maintain
for 10 years records of all adverse drug experiences required to be
reported.
The primary purpose of FDA's adverse drug experience reporting
system is to provide a signal for potentially serious safety problems
with marketed drugs. Although premarket testing discloses a general
safety profile of a new drug's comparatively common adverse effects,
the larger and more diverse patient populations exposed to the marketed
drug provide the opportunity to collect information on rare, latent,
and long-term effects. Signals are obtained from a variety of sources,
including reports from patients, treating physicians, foreign
regulatory agencies, and clinical investigators. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), decisions about risk evaluation and mitigation
strategies or the need for postmarket studies or clinical trials, and
when necessary, to initiate removal of a drug from the market.
Respondents to this collection of information are manufacturers,
packers, distributors, and applicants. 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 per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
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310.305(c)(5) 1 1 1 1 1
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314.80(c)(1)(iii) 5 1 5 1 5
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314.80(c)(2) 642 17.88 11,478 60 688,680
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Total 688,686
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\1\ The reporting burden for Sec. Sec. 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB No. 0910-0291.
The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
[[Page 76360]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
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310.305(f) 25 1 25 16 400
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314.80(i) 642 623 400,000 16 6,400,000
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Total 7,088,680
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\1\There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.
These estimates are based on FDA's knowledge of adverse drug
experience reporting, including the time needed to prepare the reports,
and the number of reports submitted to the agency.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29664 Filed 12-15-08; 8:45 am]
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