Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program, 62184-62187 [2021-24432]
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62184
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
collection of information by December
9, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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 0910–0291. Also include
the FDA docket number found in
brackets in the heading of this
document.
IV. Paperwork Reduction Act of 1995
FOR FURTHER INFORMATION CONTACT:
FDA tentatively concludes that these
draft guidances contain no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24431 Filed 11–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1960]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the 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
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:00 Nov 08, 2021
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
V. Electronic Access
AGENCY:
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, PRAStaff@
fda.hhs.gov.
Jkt 256001
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
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MedWatch program provides for both
paper-based and electronic reporting,
this information collection covers
paper-based reporting using Forms FDA
3500, 3500A, and 3500B, available from
our website at https://www.fda.gov/
safety/medical-product-safetyinformation/medwatch-forms-fdasafety-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 cellularand tissue-based products (HCT/Ps)
have been codified in § 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 postapproval 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
information collection are healthcare
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
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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
https://vaers.hhs.gov), which is jointly
administered by FDA and the Centers
for Disease Control and Prevention
(CDC).
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 devicerelated 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 (21 U.S.C. 342) 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
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17:00 Nov 08, 2021
Jkt 256001
Reporting Portal at https://
www.safetyreporting.hhs.gov/. 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
https://www.accessdata.fda.gov/scripts/
medwatch/. Respondents can also
electronically submit a report via the
MedWatch Online Voluntary Reporting
Form at https://
www.accessdata.fda.gov/scripts/
medwatch/. 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 https://www.safetyreporting.hhs.gov/.
Electronic reports for tobacco products
may be submitted to the Agency via the
tobacco questionnaire within the online
Safety Reporting Portal at https://
www.safetyreporting.hhs.gov/.
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
§ 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
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62185
and Human Services may by regulation
reasonably require to ensure that such
devices are not adulterated or
misbranded and to otherwise assure its
safety and effectiveness. The Safe
Medical Device Act of 1990 (Pub. L.
101–629), 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, as well as coverage for
MedWatch electronic reporting in OMB
control number 0910–0645.
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 https://
www.safetyreporting.hhs.gov/. Paperbased 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
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
human medical products, food, dietary
supplements, and cosmetic products
and invite these respondents to visit our
website at https://www.fda.gov/safety/
report-problem-fda 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 https://www.fda.gov/medwatch, 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
Form FDA 3500B 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 (Pub. L. 111–274) (https://
www.govinfo.gov/content/pkg/PLAW111publ274/pdf/PLAW111publ274.pdf). The Form FDA 3500B
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 Form FDA
3500B has been available in Spanish at
https://www.fda.gov/safety/medwatchfda-safety-information-and-adverseevent-reporting-program/reportingserious-problems-fda and available to
upload electronically since 2021 at
https://www.accessdata.fda.gov/scripts/
medwatch/
index.cfm?action=reporting.spanish.
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 https://
www.accessdata.fda.gov/scripts/
medwatch/. A fillable .pdf version of the
form, available at https://www.fda.gov/
media/85598/download 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 https://
www.safetyreporting.hhs.gov/.
Electronic reports for tobacco products
may be submitted to the Agency via the
tobacco questionnaire within the online
Safety Reporting Portal at https://
www.safetyreporting.hhs.gov/.
In the Federal Register of June 30,
2021 (86 FR 34754), we published a 60-
day notice requesting public comment
on the proposed collection of
information. One comment was received
requesting clarification with regard to
certain terms applicable to medical
device reporting and exemptions from
reporting. The comment also discussed
electronic reporting considerations. We
note this information collection
supports paper-based reporting,
however, we inadvertently included
estimates associated with electronic
reporting elements required under
certain device product regulations.
Electronic reporting of adverse
experiences associated with FDAregulated products is currently
approved in OMB control number 0910–
0645. We also note that information
collection associated with additional
medical device reporting requirements
is currently approved in OMB control
number 0910–0437.
At the same time, we appreciate the
request for clarification as we
continually evaluate our MedWatch
forms to increase their utility for the
Agency and ease of reporting for
respondents. To that end, we are
considering making the following
revisions and invite comment:
1. Revising the ‘‘gender’’ field to
Forms FDA 3500, 3500A, and 3500B; to
align with the CDC’s use of these terms.
2. Revising Section B of Form FDA
3500 to the ‘‘product problem’’ field to
include information about the root
cause(s) of problem(s);
3. Revising instructions to clarify
reporting instructions for paper-based
reporting pertaining to adverse events
associated with tobacco products; and
4. Revising instructions to replace the
term ‘‘smoking’’ with the term ‘‘tobacco
product use,’’ to clarify that this
information applies to the use
combusted and non-combusted tobacco
products.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
jspears on DSK121TN23PROD with NOTICES1
FDA center or 21 CFR section and/or FDA form
Number of
respondents
Center for Biologics Evaluation and Research/Center
for Drug Evaluation and Research: Form FDA
3500.
Center for Devices and Radiological Health Form
3500 (voluntary reporting).
Center for Food Safety and Applied Nutrition: Form
FDA 3500.
Form FDA 3500A ........................................................
Center for Tobacco Products: Form FDA 3500 ..........
All Centers: Form 3500B .............................................
Written requests for temporary waiver under
§ 329.100(c)(2).
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Frm 00046
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
14,727
1
14,727
0.66 (40 minutes) ..
9,720
5,233
1
5,233
0.66 (40 minutes) ...
3,454
1,793
1
1,793
0.66 (40 minutes) ..
1,183
1,659
39
13,750
1
1
1
1
1
1,659
39
13,750
1
1.21 ........................
0.66 (40 minutes) ..
0.46 (28 minutes) ...
1 .............................
2,007
26
6,325
1
Fmt 4703
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
62187
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
FDA center or 21 CFR section and/or FDA form
Total ......................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
................................
Total hours
22,716
are no capital costs or operating and maintenance costs associated with this collection of information.
While we have retained the currently
approved burden estimates for the
individual information collection
elements, we have removed those
elements associated with mandatory
electronic reporting inadvertently
included in our 60-day notice, as these
elements are currently approved under
OMB control number 0910–0645.
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24432 Filed 11–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
The meeting will be open to the
public as indicated below, with a short
public comment period at the end. The
open session will be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov).
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
jspears on DSK121TN23PROD with NOTICES1
Number of
respondents
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Digestive Diseases and Nutrition
Subcommittee.
Date: January 26–27, 2022.
Time: 10:00 a.m. to 1:45 p.m.
Agenda: Grant applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
VerDate Sep<11>2014
17:00 Nov 08, 2021
Jkt 256001
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Kidney, Urologic and Hematologic
Diseases Subcommittee.
Date: January 26–27, 2022.
Time: 10:00 a.m. to 1:45 p.m.
Agenda: Grant applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Diabetes, Endocrinology and
Metabolic Diseases Subcommittee.
Date: January 26–27, 2022.
Time: 10:00 a.m. to 1:45 p.m.
Agenda: Grant applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: January 26–27, 2022.
Open: January 26, 2022, 10:00 a.m. to 1:15
p.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Closed: January 27, 2022, 1:25 p.m. to 1:45
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/fund/divisions/DEA/
Council/coundesc.htm., where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 3, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24439 Filed 11–8–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Library of
Medicine Board of Scientific
Counselors.
The meeting will be open to the
public as indicated below. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations should notify the
Contact Person listed below in advance
of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
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]]>Agencies
[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62184-62187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24432]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1960]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, the 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 9, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0291. 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,
[email protected].
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.
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
using Forms FDA 3500, 3500A, and 3500B, available from our website at
https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-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 information collection are healthcare
[[Page 62185]]
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 https://vaers.hhs.gov), which is jointly administered by
FDA and the Centers for Disease Control and Prevention (CDC).
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 (21 U.S.C. 342) 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 https://www.safetyreporting.hhs.gov/. 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 https://www.accessdata.fda.gov/scripts/medwatch/.
Respondents can also electronically submit a report via the MedWatch
Online Voluntary Reporting Form at https://www.accessdata.fda.gov/scripts/medwatch/. 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 https://www.safetyreporting.hhs.gov/. Electronic reports for tobacco products
may be submitted to the Agency via the tobacco questionnaire within the
online Safety Reporting Portal at https://www.safetyreporting.hhs.gov/.
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 ensure that such devices are not adulterated or misbranded
and to otherwise assure its safety and effectiveness. The Safe Medical
Device Act of 1990 (Pub. L. 101-629), 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, as well as coverage for MedWatch
electronic reporting in OMB control number 0910-0645.
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 https://www.safetyreporting.hhs.gov/. 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
[[Page 62186]]
human medical products, food, dietary supplements, and cosmetic
products and invite these respondents to visit our website at https://www.fda.gov/safety/report-problem-fda 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
https://www.fda.gov/medwatch, 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 Form FDA 3500B 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 (Pub. L.
111-274) (https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf). The Form FDA 3500B 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 Form FDA 3500B has been
available in Spanish at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda and available to upload electronically since 2021 at
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish.
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 https://www.accessdata.fda.gov/scripts/medwatch/. A fillable .pdf version of
the form, available at https://www.fda.gov/media/85598/download 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 https://www.safetyreporting.hhs.gov/. Electronic reports for
tobacco products may be submitted to the Agency via the tobacco
questionnaire within the online Safety Reporting Portal at https://www.safetyreporting.hhs.gov/.
In the Federal Register of June 30, 2021 (86 FR 34754), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification with regard to certain terms applicable to medical device
reporting and exemptions from reporting. The comment also discussed
electronic reporting considerations. We note this information
collection supports paper-based reporting, however, we inadvertently
included estimates associated with electronic reporting elements
required under certain device product regulations. Electronic reporting
of adverse experiences associated with FDA-regulated products is
currently approved in OMB control number 0910-0645. We also note that
information collection associated with additional medical device
reporting requirements is currently approved in OMB control number
0910-0437.
At the same time, we appreciate the request for clarification as we
continually evaluate our MedWatch forms to increase their utility for
the Agency and ease of reporting for respondents. To that end, we are
considering making the following revisions and invite comment:
1. Revising the ``gender'' field to Forms FDA 3500, 3500A, and
3500B; to align with the CDC's use of these terms.
2. Revising Section B of Form FDA 3500 to the ``product problem''
field to include information about the root cause(s) of problem(s);
3. Revising instructions to clarify reporting instructions for
paper-based reporting pertaining to adverse events associated with
tobacco products; and
4. Revising instructions to replace the term ``smoking'' with the
term ``tobacco product use,'' to clarify that this information applies
to the use combusted and non-combusted tobacco products.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA center or 21 CFR section and/or FDA form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/ 14,727 1 14,727 0.66 (40 minutes)........................ 9,720
Center for Drug Evaluation and Research:
Form FDA 3500.
Center for Devices and Radiological Health 5,233 1 5,233 0.66 (40 minutes)........................ 3,454
Form 3500 (voluntary reporting).
Center for Food Safety and Applied Nutrition: 1,793 1 1,793 0.66 (40 minutes)........................ 1,183
Form FDA 3500.
Form FDA 3500A............................... 1,659 1 1,659 1.21..................................... 2,007
Center for Tobacco Products: Form FDA 3500... 39 1 39 0.66 (40 minutes)........................ 26
All Centers: Form 3500B...................... 13,750 1 13,750 0.46 (28 minutes)........................ 6,325
Written requests for temporary waiver under 1 1 1 1........................................ 1
Sec. 329.100(c)(2).
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[[Page 62187]]
Total.................................... .............. .............. .............. ......................................... 22,716
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
While we have retained the currently approved burden estimates for
the individual information collection elements, we have removed those
elements associated with mandatory electronic reporting inadvertently
included in our 60-day notice, as these elements are currently approved
under OMB control number 0910-0645.
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24432 Filed 11-8-21; 8:45 am]
BILLING CODE 4164-01-P
