[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]
[Page 22882-22884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0157]
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 July 5, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the
collection of information to the Division of Dockets 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: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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 requirement 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
[[Page 22883]]
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 09109-0230)--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 action necessary for protection of 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 obtained in scientific literature and from
postmarketing epidemiological/surveillance studies. 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, 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
for 10 years records of all adverse drug experience reports known to
the applicant.
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)). 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 provides, for the first time, 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) 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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Annual Frequency per Total Annual Hours Per
21 CFR Section No. of Respondents Response Responses Response Total Hours
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310.305(c)(5) 1 1 1 1 1
314.80(c)(1)(ii 5 1 5 1 5
i)
314.80(c)(2) 530 20 10,614 28 297,192
Total ..................... ..................... ............... ............... 297,198
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Record Total Hours
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310.305(f) 25 1 25 1 25
314.80(i) 530 1 530 1 530
Total ..................... ..................... ..................... ..................... 555
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 22884]]
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 during 2004.
Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8737 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S