[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55900-55902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24442]


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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 and Biological Product Experience Reporting and Recordkeeping

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 
December 10, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of

[[Page 55901]]

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 and Biological Product Experience Reporting 
and Recordkeeping

OMB Control Number 0910-0230--Revision

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) (FD&C Act) require that 
marketed drugs be safe and effective. To monitor the safety and 
efficacy of drugs that are on the market, FDA must be promptly informed 
of adverse experiences associated with the use of marketed drugs. We 
have issued regulations at Sec. Sec.  310.305 and 314.80 (21 CFR 
310.305 and 314.80) to implement reporting and recordkeeping 
requirements that enable us to take necessary action to protect the 
public health from adverse drug experiences.
    All applicants who have received marketing approval of drug 
products are required to report 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 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, 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(j), 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(g), each manufacturer, 
packer, and distributor shall maintain for 10 years records of all 
adverse drug experiences required to be reported.
    Section 760 of the Act (21 U.S.C. 379aa), also provides for 
mandatory safety reporting for over-the-counter (OTC) human drug 
products not subject to applications approved under section 505 of the 
Act (new drug applications or abbreviated new drug applications). These 
requirements apply to all OTC) drug products marketed without an 
approved application, including those marketed under the OTC Drug 
Monograph Review process (whether or not subject to a final monograph), 
those marketed outside the monograph system, and including those that 
have been discontinued from marketing but for which a report of an 
adverse event was received. Under 21 CFR part 329.100 respondents must 
submit section 760 reports in an electronic format.
    To assist respondents with implementation of section 760 we 
developed the guidance document entitled ``Postmarketing Adverse Event 
Reporting for Nonprescription Human Drug Products Marketed Without an 
Approved Application.'' The guidance document discusses what should be 
included in a serious adverse drug event report submitted under section 
760(b)(1) of the FD&C Act (21 U.S.C. 379aa(b)(1)), including follow-up 
reports under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and 
how to submit these reports.
    Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires 
that responsible persons maintain records of nonprescription adverse 
event reports, whether or not the event is serious, for a period of 6 
years. The guidance recommends that respondents maintain records of 
efforts to obtain the minimum data elements for a report of a serious 
adverse drug event and any follow-up reports. The information 
collection associated with the guidance is currently approved under OMB 
Control No. 0910-0636, however we are now consolidating it into this 
collection.
    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 us to make important changes 
to the product's labeling (such as adding a new warning), to make 
decisions about risk evaluation and mitigation strategies or the need 
for postmarketing studies or clinical trials, and when necessary, to 
initiate removal of a drug from the market.
    In the Federal Register of July 11, 2018 (83 FR 32132) we published 
a 60-day notice requesting public comment on the proposed collection of 
information approved under OMB Control No. 0910-0230. One comment from 
an anonymous source referred us to attachments that were not 
successfully transmitted. We are therefore unable to address this 
comment. In the Federal Register of August 15, 2018 (83 FR 40520) we 
published a 60-day notice requesting public comment on the collection 
of information approved under OMB Control No 0910-0636. No comments 
were received.
    Respondents to the collection of information are manufacturers, 
packers, distributors, and applicants of FDA-regulated drug and 
biological products. The following estimates are based on our knowledge 
of adverse drug experience reporting, including the time needed to 
prepare the reports and the number of reports submitted to the Agency.
    We estimate the burden of this collection of information as 
follows:

[[Page 55902]]



                               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
----------------------------------------------------------------------------------------------------------------
310.305(c)(5)...................               3               1               3               1               3
314.80(c)(1)(iii)...............               5               1               5               1               5
314.80(c)(2)....................             810           17.19       13,923.90              60         835,434
Reports of serious adverse drug              283         687.099         194,449               6       1,166,694
 events (21 U.S.C. 379aa((b) and
 (c))...........................
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    Total.......................  ..............  ..............  ..............  ..............       2,002,136
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\1\ The reporting burden for Sec.   310.305(c)(1), (2), and (3), and Sec.   314.80(c)(1)(i) and (ii) is covered
  under OMB control number 0910-0645.
\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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                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305(g)......................              25               1              25              16             400
314.80(j).......................             352           1,870         658,240              16      10,531,840
Recordkeeping (21 U.S.C.                     300        885.6667         265,700               8       2,125,600
 379aa(e)(1))...................
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    Total.......................  ..............  ..............  ..............  ..............      12,657,840
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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.

    Based on submissions received we have increased our burden estimate 
for reporting under part 314.80(c)(2) and recordkeeping under part 
314.80(j). Additionally, and as previously stated, we are consolidating 
burden associated with reporting and recordkeeping under section 760 of 
the FD&C Act. Based on our records, we received 194,449 total annual 
reports from approximately 283 respondents for nonprescription drugs 
marketed without an approved application. We estimate each submission 
takes approximately 6 hours to prepare and submit. We estimate that 
there are 265,700 records per year maintained by approximately 300 
respondents, and that it takes 8 hours to maintain each record.

     Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24442 Filed 11-7-18; 8:45 am]
 BILLING CODE 4164-01-P