[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]
BILLING CODE 4160-01-S