
[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38303-38305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarketing Adverse 
Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 38304]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
27, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0230. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 (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 follow up 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 follow-up reports when 
needed (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the 
submission of follow-up 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.
    In the Federal Register of March 20, 2012 (77 FR 16232), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received several comments, but they did 
not pertain to the information collection in 21 CFR 310.305(c)(5) and 
(f), and 314.80(c)(1)(iii), (c)(2), and (i).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Number of
                        21 CFR Section                              Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per 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
                                                               -----------------------------------------------------------------------------------------
    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 No. 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 burden
                        21 CFR Section                              Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
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310.305(f)....................................................                25                 1                25                16               400

[[Page 38305]]

 
314.80(i).....................................................               665             601.5           399,998                16         6,399,968
                                                               -----------------------------------------------------------------------------------------
    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: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15708 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P


