[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32132-32134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14799]


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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 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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 September 10, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 10, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and

[[Page 32133]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0253 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Postmarketing Adverse Drug and 
Biological Product Experience Reporting and Recordkeeping.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
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 and Biological Product Experience Reporting 
and Recordkeeping

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. 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. FDA issued 
regulations at Sec. Sec.  310.305 and 314.80 (21 CFR 310.305 and 
314.80) to implement 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 followup 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 followup reports (Sec.  
310.305(c)). Section 310.305(c)(5) pertains to the submission of 
followup 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.
    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

[[Page 32134]]

public health protection because the information enables FDA 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.
    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).............................................                810              17.19          13,923.90                 60            835,434
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    Total................................................  .................  .................  .................  .................            835,442
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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 0910-0291.
\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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                                                               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(g)...............................................                 25                  1                 25                 16                400
314.80(j)................................................                352              1,870            658,240                 16         10,531,840
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................         10,532,240
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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.

    The burden associated with table 2 has increased due to the 
electronic Safety Reporting Rule that mandated sponsors to submit ALL 
reports electronically by September 2016. Prior to this date, FDA did 
not enter all individual report data in document tracking systems or 
count some types of paper-based nonexpedited reports (i.e., those 
describing adverse events that are both nonserious and previously 
labeled). With required electronic reporting of all reports and each 
report counted separately, the total number of records and required 
recordkeeping also increased.

    Dated: July 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14799 Filed 7-10-18; 8:45 am]
 BILLING CODE 4164-01-P