Document ID: FDA-2012-N-0253-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarketing Adverse Drug Experience Reporting
Posted Date: 2012-03-20T04:00Z

[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16232-16234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]

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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[[Page 16233]]

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 either written or electronic comments on the collection 
of information by May 21, 2012.

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 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.Vilela@FDA.hhs.gov.

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: (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 (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 
nonapplicants. 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 
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)). 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:

[[Page 16234]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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310.305(c)(5)...................               3               1               3               1               3
314.80(c)(1)(iii)...............               5               1               5               1               5
314.80(c)(2)....................             665           22.85          15,195              60         911,700
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    Total.......................  ..............  ..............  ..............  ..............         911,708
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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)
  is reported under OMB control number 0910-0291. The capital costs or operating and maintenance costs
  associated with this collection of information are approximately $25,000 annually.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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310.305(f)......................              25               1              25              16             400
314.80(i).......................             665           601.5         399,998              16       6,399,968
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    Total.......................  ..............  ..............  ..............  ..............       6,400,368
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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.

    Dated: March 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6692 Filed 3-19-12; 8:45 am]
BILLING CODE 4160-01-P