Notice2021-13943
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
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
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 information collection associated with FDA's MedWatch adverse experience reporting (AER) program.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 123 (Wednesday, June 30, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34754-34757]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13943]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1960]
Agency Information Collection Activities; Proposed Collection;
Comment Request; MedWatch: The Food and Drug Administration Medical
Products Reporting Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 information collection
associated with FDA's MedWatch adverse experience reporting (AER)
program.
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.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1960 for ``MedWatch: The FDA Medical Products Reporting
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential
[[Page 34755]]
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#79292b382a0d181f1f391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="752527342601141313351311145b1d1d065b121a03">[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.
MedWatch: The FDA Medical Products Reporting Program
OMB Control Number 0910-0291--Extension
This information collection supports FDA laws and regulations
governing adverse event reports and product experience reports for FDA-
regulated products. The Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353b, 355, 360i, 360l, 379aa, and 393) and the Public Health
Service Act (42 U.S.C. 262) authorize FDA to collect adverse event
reports and product experience reports from regulated industry and to
monitor the safety of drugs, biologics, medical devices, and dietary
supplements. These reporting and recordkeeping requirements are found
in FDA regulations, discussed in Agency guidance, and included in
Agency forms. Although there are no laws or regulations mandating
postmarket reporting for medical foods, infant formula, cosmetics, or
tobacco products, we encourage voluntary reporting of adverse
experiences associated with these products.
To facilitate both consumer and industry reporting of adverse
events and experiences with FDA-regulated products, we developed the
MedWatch program. The MedWatch program allows anyone to submit reports
to FDA on adverse events, including injuries and/or deaths, as well as
other product experiences associated with the products we regulate.
While the MedWatch program provides for both paper-based and electronic
reporting, this information collection covers paper-based reporting.
Requirements regarding mandatory reporting of adverse events or product
problems have been codified in parts 310, 314, 329, 600, and 803 (21
CFR 310, 314, 600, and 803), and specified in sections 503B, 760, and
761 of the FD&C Act (21 U.S.C. 353b, 379aa, and 379aa-1). Mandatory
reporting of adverse events for human cells, tissues, and cellular- and
tissue-based products (HCT/Ps) have been codified in Sec. 1271.350 (21
CFR 1271.350). Other postmarketing reporting associated with
requirements found in sections 201, 502, 505, and 701 (21 U.S.C. 321,
352, 355, and 371) of the FD&C Act and applicable to certain drug
products with and without approved applications are approved under OMB
control number 0910-0230.
Since 1993, mandatory adverse event reporting has been supplemented
by voluntary reporting by healthcare professionals, patients, and
consumers via the MedWatch reporting process. To carry out its
responsibilities, the Agency needs to be informed when an adverse
event, product problem, error with use of a human medical product, or
evidence of therapeutic failure is suspected or identified in clinical
use. When FDA receives this information from healthcare professionals,
patients, or consumers, the report becomes data that will be used to
assess and evaluate the risk associated with the product. FDA will take
any necessary action to reduce, mitigate, or eliminate the public's
exposure to the risk through regulatory and public health
interventions.
To implement these reporting provisions for FDA-regulated products
(except vaccines) during their post-approval and marketed lifetimes, we
developed the following three forms, available for download from our
website or upon request to the Agency: (1) Form FDA 3500 may be used
for voluntary (i.e., not mandated by law or regulation) reporting by
healthcare professionals; (2) Form FDA 3500A is used for mandatory
reporting (i.e., required by law or regulation); and (3) Form FDA
3500B, available in English and Spanish, is written in plain language
and may be used for voluntary reporting (i.e., not mandated by law or
regulation) by consumers (i.e., patients and their caregivers).
Respondents to the
[[Page 34756]]
information collection are healthcare professionals, medical care
organizations and other user facilities (e.g., extended care
facilities, ambulatory surgical centers), consumers, manufacturers of
biological, food products including dietary supplements and special
nutritional products (e.g., infant formula and medical foods),
cosmetics, drug products or medical devices, and importers.
Use of Form FDA 3500 (Voluntary Reporting)
This voluntary version of the form may be used by healthcare
professionals to submit all reports not mandated by Federal law or
regulation. Individual healthcare professionals are not required by law
or regulation to submit reports to the Agency or the manufacturer, with
the exception of certain adverse events following immunization with
vaccines as mandated by the National Childhood Vaccine Injury Act of
1986. Reports for vaccines are not submitted via MedWatch or MedWatch
forms, but are submitted to the Vaccines Adverse Event Reporting System
(VAERS; see <a href="http://vaers.hhs.gov">http://vaers.hhs.gov</a>), which is jointly administered by FDA
and the Centers for Disease Control and Prevention.
Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries.
Under Federal law and regulation (section 761(b)(1) of the FD&C
Act), a dietary supplement manufacturer, packer, or distributor whose
name appears on the label of a dietary supplement marketed in the
United States is required to submit to FDA any serious adverse event
report it receives regarding use of the dietary supplement in the
United States. However, FDA bears the burden to gather and review
evidence that a dietary supplement may be adulterated under section 402
of the FD&C Act after that product is marketed. Therefore, the Agency
depends on the voluntary reporting by healthcare professionals and
especially by consumers of suspected serious adverse events and product
quality problems associated with the use of dietary supplements. All
dietary supplement reports were originally received by the Agency on
paper versions of Form FDA 3500 (by mail or fax). Today, electronic
reports may be sent to the Agency via an online submission route called
the Safety Reporting Portal at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>. In
that case, the Form FDA 3500 is not used.
Form FDA 3500 may be used to report to the Agency adverse events,
product problems, product use errors, and therapeutic failures. The
form is provided in both paper and electronic formats. Reporters may
mail or fax paper forms to the Agency. A fillable .pdf version of the
form is available at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>
or electronically submit a report via the MedWatch Online Voluntary
Reporting Form at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>.
Reporting is supported for drugs, non-vaccine biologicals, medical
devices, food products, special nutritional products, cosmetics, and
non-prescription human drug products marketed without an approved
application. The paper form may also be used to submit reports about
dietary supplements. Electronic reports for dietary supplements may be
submitted to the Agency via an online submission route called the
Safety Reporting Portal at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>.
Electronic reports for tobacco products may be submitted to the Agency
via the tobacco questionnaire within the online Safety Reporting Portal
at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>.
Use of Form FDA 3500A--Mandatory Reporting
Drug and Biological Products
Sections 503B, 505(j), and 704 of the FD&C Act (21 U.S.C. 374)
require that important safety information relating to all human
prescription drug products be made available to FDA in the event it
becomes necessary to take appropriate action to ensure protection of
the public health. Mandatory reporting of adverse events for HCT/Ps is
codified in Sec. 1271.350. Consistent with statutory requirements,
information is required to be submitted electronically and therefore we
account for most all reports under OMB control number 0910-0645,
established to support electronic reporting to our MedWatch program. At
the same time, regulations provided for waivers from the electronic
submission requirements and we therefore account for paper-based
reporting in this information collection.
Medical Device Products
Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers
and importers, of devices intended for human use to establish and
maintain records, make reports, and provide information as the
Secretary of Health and Human Services may by regulation reasonably
require to assure that such devices are not adulterated or misbranded
and to otherwise assure its safety and effectiveness. The Safe Medical
Device Act of 1990, signed into law on November 28, 1990, amends
section 519 of the FD&C Act. The amendment requires that user
facilities such as hospitals, nursing homes, ambulatory surgical
facilities, and outpatient treatment facilities report deaths related
to medical devices to FDA and to the manufacturer, if known. Serious
illnesses and injuries are to be reported to the manufacturer or to FDA
if the manufacturer is not known. These statutory requirements
regarding mandatory reporting have been codified by FDA under 21 CFR
part 803 (part 803). Part 803 mandates the use of the Form FDA 3500A
for reporting to FDA on medical devices. While most reporting
associated with medical device products is covered under OMB control
number 0910-0437, we retain coverage for paper-based adverse experience
report submissions in this collection.
Dietary Supplements
Section 502(x) in the FD&C Act implements the requirements of The
Dietary Supplement and Nonprescription Drug Consumer Protection Act,
which became law (Pub. L. 109-462) on December 22, 2006. These
requirements apply to manufacturers, packers, and distributors of
nonprescription human drug products marketed without an approved
application. The law requires reports of serious adverse events to be
submitted to the Agency by manufacturers of dietary supplements.
Electronic reports for dietary supplements may be submitted using the
Safety Reporting Portal at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>. Paper-
based dietary supplement reports may be submitted using the MedWatch
Form FDA 3500A.
Use of Form FDA 3500B--Consumer Voluntary Reporting
This voluntary version of the form may be used by consumers,
patients, or caregivers to submit reports not mandated by Federal law
or regulation. Individual consumers, patients, or caregivers are not
required by law or regulation to submit reports to the Agency or the
manufacturer. FDA supports and encourages direct reporting to the
Agency by consumers of suspected adverse events and other product
problems associated with human medical products, food, dietary
supplements, and cosmetic products and invite these respondents to
visit our
[[Page 34757]]
website at <a href="https://www.fda.gov/safety/report-problem-fda">https://www.fda.gov/safety/report-problem-fda</a> for more
information. Since the inception of the MedWatch program in July 1993,
the program has been promoting and facilitating voluntary reporting by
both the public and healthcare professionals. FDA has further
encouraged voluntary reporting by requiring inclusion of the MedWatch
toll-free phone number or the MedWatch internet address on all
outpatient drug prescriptions dispensed, as mandated by section 17 of
the Best Pharmaceuticals for Children Act (Pub. L. 107-109).
Section 906 of the FDA Amendments Act amended section 502(n) of the
FD&C Act, mandating that published direct-to-consumer advertisements
for prescription drugs include the following statement printed in
conspicuous text (this includes vaccine products): ``You are encouraged
to report negative side effects of prescription drugs to the FDA. Visit
<a href="https://www.fda.gov/medwatch">https://www.fda.gov/medwatch</a>, or call 1-800-FDA-1088.'' Most private
vendors of consumer medication information, the drug product-specific
instructions dispensed to consumers at outpatient pharmacies, remind
patients to report ``side effects'' to FDA and provide contact
information to permit MedWatch reporting.
Since 2013, FDA has made available the 3500B form. Proposed during
the previous authorization in 2012, the 3500B form is a version of the
3500 form that is tailored for consumers and written in plain language
in conformance with the Plain Writing Act of 2010 (<a href="https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf">https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf</a>).
The 3500B form evolved from several iterations of draft versions, with
input from human factors experts, from other regulatory agencies and
with extensive input from consumer advocacy groups and the public.
Since 2019, the 3500B form has been available in Spanish at <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda">https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda</a> and available to
upload electronically since 2021 at <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish">https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish</a>.
Form FDA 3500B, may be used to report adverse events, product
problems, product use errors and problems after switching from one
product maker to another maker to the Agency. The form is provided in
both paper and electronic formats. Respondents may submit reports by
mail or fax paper forms to the Agency or electronically submit a report
via the MedWatch Online Voluntary Reporting Form at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>. A fillable .pdf version of
the form, available at <a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf">http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf</a> may be downloaded, completed,
and mailed or faxed to the Agency. Reporting is supported for drugs,
non-vaccine biologicals, medical devices, food products, special
nutritional products, cosmetics, and non-prescription human drug
products marketed without an approved application. The paper form may
also be used to submit reports about dietary supplements. Electronic
reports for dietary supplements may be submitted to the Agency via an
online submission route called the Safety Reporting Portal at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>. Electronic reports for tobacco products
may be submitted to the Agency via the tobacco questionnaire within the
online Safety Reporting Portal at <a href="http://www.safetyreporting.hhs.gov/">http://www.safetyreporting.hhs.gov/</a>.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FDA center or 21 CFR section and/ Number of responses per Total annual Average burden Total hours
or FDA form respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation 14,727 1 14,727 0.66 (40 9,720
and Research/Center for Drug minutes)
Evaluation and Research: Form
3500...........................
Form 3500A(Sec. Sec. 310.305, 599 98 58,702 1.21 71,029
314.80, 314.98, 600.80, and
1271.350)......................
Form 3500A (Sec. 310.305 50 2 100 1.21 121
outsourcing facilities)........
Center for Devices and 5,233 1 5,233 0.66 (40 3,454
Radiological Health: Form 3500. minutes)
Form 3500A (part 803)........... 2,277 296 673,992 1.21 815,530
Center for Food Safety and 1,793 1 1,793 0.66 (40 1,183
Applied Nutrition: Form 3500... minutes)
Form 3500A...................... 1,659 1 1,659 1.21 2,007
Center for Tobacco Products: 39 1 39 0.66 (40 26
Form 3500...................... minutes)
All Centers: Form 3500B......... 13,750 1 13, 750 0.46 (28 6,325
minutes)
Written requests for temporary 1 1 1 1 1
waiver under Sec.
329.100(c)(2)..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 909,396
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We are retaining the currently approved burden estimates for the
information collection.
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13943 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 30, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.