Notice2021-24236
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 5, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 86 Issue 212 (Friday, November 5, 2021)</title>
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[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61277-61279]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24236]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0515]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Experience Reporting and Recordkeeping for Drug and Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by December 6, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 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,
<a href="/cdn-cgi/l/email-protection#b4e4e6f5e7c0d5d2d2f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="29797b687a5d484f4f694f4d480741415a074e465f">[email protected]</span></a>.
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 Experience Reporting and Recordkeeping for Drug
and Biologics Products
OMB Control Number 0910-0230--Revision
This information collection supports statutory provisions set forth
in the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the
monitoring of FDA-regulated products. Specifically,
[[Page 61278]]
FDA must be promptly informed of adverse experiences associated with
the use of marketed drugs, including human drugs and biological
products. Regulations in Sec. Sec. 310.305 and 314.80 (21 CFR 310.305
and 314.80) implement reporting and recordkeeping requirements that
enable FDA to take action to protect the public health from adverse
drug experiences. All applicants who have received marketing approval
for drug products are required to report serious, unexpected adverse
drug experiences (15-day ``Alert reports''), as well as followup
reports (Sec. 314.80(c)(1)) to FDA. 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. For the reporting interval, a periodic
report includes reports of serious, expected adverse drug experiences,
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 (NDAs) or abbreviated new drug applications (ANDAs),
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.
Section 760 of the FD&C 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
FD&C Act (21 U.S.C. 355) (NDAs or ANDAs). 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 329.100, respondents must submit reports according to
section 760 of the FD&C Act in an electronic format.
To assist respondents with implementation of section 760 of the
FD&C Act, FDA developed the guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application,'' available at
<a href="https://www.fda.gov/media/77193/download">https://www.fda.gov/media/77193/download</a>. 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, including how
to submit these reports and followup reports under section 760(c)(2) of
the FD&C Act.
Section 760(e) of the FD&C Act also requires that responsible
persons maintain records of nonprescription drug adverse event reports,
whether the event is serious or not, for a period of 6 years. FDA's
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 followup reports.
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), 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 product from the market.
In addition, this information collection includes an International
Council for Harmonisation (ICH) guidance for industry entitled
``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2)
Format (Periodic Benefit-Risk Evaluation Report),'' available at
<a href="https://www.fda.gov/media/85520/download">https://www.fda.gov/media/85520/download</a>. The guidance describes the
conditions under which applicants may use the ICH3 E2C(R2) Periodic
Benefit-Risk Evaluation Report format for certain types of adverse
event reporting. FDA regulations in Sec. Sec. 314.80(c)(2) and
600.80(c)(2) (21 CFR 600.80(c)(2)) require applicants to submit
postmarketing periodic safety reports for each approved application.
The reports must be submitted quarterly for the first 3 years following
the U.S. approval date and annually thereafter and must contain the
information described in Sec. Sec. 314.80(c)(2)(ii) and
600.80(c)(2)(ii) (the information collection associated with 21 CFR
part 600--Biological Products, is approved under OMB control number
0910-0308). The Agency guidance assists respondents with satisfying the
regulatory requirements in an alternative format, noting that the
process differs depending on whether an applicable periodic safety
update report (PSUR) waiver is in place. The information collection
burden for waivers of a PSUR are currently approved in OMB control
number 0910-0771; however, it is being consolidated with this
information collection for administrative efficiency.
Similarly, the information collection accounts for burden that may
be applicable to the guidance document, ``Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During a
Pandemic,'' available at <a href="https://www.fda.gov/media/72498/download">https://www.fda.gov/media/72498/download</a>. In
response to the Coronavirus Disease 2019 public health emergency, we
revised the Agency guidance document to provide recommendations for
recordkeeping applicable to any pandemic, not just influenza, including
recommendations for planning, notification, and documentation for
continuity of operations for firms that report postmarketing adverse
events during any pandemic.
Respondents to this collection of information are: (1)
Manufacturers, packers, distributors, and applicants of FDA-regulated
drug and biologic products; (2) manufacturers, packers, and
distributors of marketed prescription drug products without an FDA-
approved application; and (3) manufacturers, packers, and distributors
of marketed nonprescription drug products, including OTC drug products
marketed without an approved application, OTC drug products marketed
under the OTC Drug Monograph Review process (whether subject to a final
monograph or not), and
[[Page 61279]]
drug products marketed outside the monograph system.
In the Federal Register of June 30, 2021 (86 FR 34759), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section or type of Number of responses per Total annual Average burden Total hours
respondent and activity 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).................. 820 17.32 14,202 60 852,120
Reports of serious adverse 285 690 196,650 6 1,179,900
drug events (Sec. 329.100).
Applicants that have a PSUR 55 3.4 187 1 187
waiver for an approved
application..................
Applicants that do not have a 29 2.3 67 2 134
PSUR waiver for an approved
application..................
Notifying FDA when normal 350 1 350 8 2,800
reporting is not feasible....
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Total \2\................. ............... .............. 211,464 ............... 2,035,149
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\1\ 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\
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Number of Average burden
21 CFR section or FD&C act Number of records per Total annual per Total hours
section and activity recordkeepers recordkeeper records recordkeeping
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310.305....................... 25 1 25 16 400
314.80(j)..................... 352 1,870 658,240 16 10,531,840
Recordkeeping of 300 885.6667 265,700 8 2,125,600
nonprescription drug adverse
event reports (Section
760(e)(1) of the FD&C Act)...
Adding Adverse Event report 100 1 100 50 5,000
planning to Continuity of
Operations Plans.............
Maintaining documentation of 350 1 350 8 2,800
pandemic conditions and
resultant high absenteeism...
Maintaining records to 350 1 350 8 2,800
identify what reports have
been stored and when the
reporting process was
restored.....................
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Total \2\................. ............... .............. 924,765 ............... 12,668,440
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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.
We have increased our estimate to reflect expected adjustments to
the information collection since our last submission for OMB review and
approval.
Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24236 Filed 11-4-21; 8:45 am]
BILLING CODE 4164-01-P
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