83 FR 32132 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 133 (July 11, 2018)

Page Range		32132-32134
FR Document		2018-14799

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.

Federal Register, Volume 83 Issue 133 (Wednesday, July 11, 2018)

[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32132-32134]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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
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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

Document Created: 2018-07-10 23:54:13
Document Modified: 2018-07-10 23:54:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by September 10, 2018.
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]
FR Citation		83 FR 32132

83 FR 32132 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 133 (July 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration