Notice2021-13968
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products
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Published
June 30, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.
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<title>Federal Register, Volume 86 Issue 123 (Wednesday, June 30, 2021)</title>
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[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34759-34762]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0515]
Agency Information Collection Activities; Proposed Collection;
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 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 postmarketing reporting and
recordkeeping of adverse experiences for drug and biological products.
DATES: Submit either electronic or written comments on the collection
of information by August 30, 2021.
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 August 30, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 30, 2021. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 identified,
as confidential, if submitted as detailed in ``Instructions.''
[[Page 34760]]
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0515 for ``Postmarketing Adverse Experience Reporting and
Recordkeeping for Drug and Biological Products.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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#f1a1a3b0a285909797b1979590df999982df969e87"><span class="__cf_email__" data-cfemail="a5f5f7e4f6d1c4c3c3e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 Experience Reporting and Recordkeeping for Drug
and Biologics Products
OMB Control Number 0910-0230--Extension
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, 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
[[Page 34761]]
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 drug products marketed outside the monograph
system.
FDA estimates 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 drug 285 690 196,650 6 1,179,900
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 reporting burden for Sec. Sec. 310.305(c)(1), (2), and (3), and 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.
[[Page 34762]]
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)....................... 325 2,025 658,240 16 10,531,840
Recordkeeping of nonprescription 300 885.6667 265,700 8 2,125,600
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 identify 350 1 350 8 2,800
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.
The information collection reflects adjustments resulting in an
overall decrease in burden hours and an increase in annual responses.
We believe these adjustments reflect expected fluctuations in burden
and invite comment on our assumptions.
Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13968 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P
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