
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13009-13011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05591]


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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 and 
Recordkeeping Biological Products

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 the information collection 
provisions of FDA's postmarketing adverse drug experience reporting and 
recordkeeping requirements.

DATES: Submit either electronic or written comments on the collection 
of information by May 11, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

[[Page 13010]]

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 (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 associated with 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 (``15-day Alert reports''), as well as follow up reports 
(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, an analysis of the 15-day Alert reports submitted during 
the reporting interval, 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 (Sec.  
310.305(c)). Section 310.305(c)(5) pertains to the submission of 
follow-up reports to reports forwarded to the manufacturers, packers, 
and distributors 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 enable identification of signals 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. The following 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
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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).............................................                724              19.33             13,996                 60            839,760
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    Total................................................  .................  .................  .................  .................            839,768
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\1\ The reporting burden for Sec.   310.305(c)(1), (c)(2), and (c)(3), and Sec.   314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910-
  0291.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.

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                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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310.305(f)...............................................                 25                  1                 25                 16                400
314.80(i)................................................                724                508            367,959                 16          5,887,344
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    Total................................................  .................  .................  .................  .................          5,887,744
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\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.


    Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05591 Filed 3-11-15; 8:45 am]
 BILLING CODE 4164-01-P


