
[Federal Register: March 13, 2009 (Volume 74, Number 48)]
[Notices]               
[Page 10924-10926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr09-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0633]

 
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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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 April 
13, 2009.

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: 202-395-6974, or e-mailed 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: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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 (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

[[Page 10925]]

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.
    In the Federal Register of December 16, 2008 (73 FR 76358), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received on the information 
collection.
    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 control 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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                                                              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.



[[Page 10926]]

    Dated: March 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5494 Filed 3-12-09; 8:45 am]

BILLING CODE 4160-01-S
