[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35957-35958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15319]


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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 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 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 
22, 2015.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 (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

[[Page 35958]]

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.
    In the Federal Register of March 12, 2015 (80 FR 13009), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                                   No. of        No. of responses    Total annual      Average burden
                       21 CFR section                           respondents       per respondent       responses        per response       Total hours
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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
                                                            --------------------------------------------------------------------------------------------
    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.


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                                   No. of         No. 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
                                                            --------------------------------------------------------------------------------------------
    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: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15319 Filed 6-22-15; 8:45 am]
BILLING CODE 4164-01-P