Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program, 11756-11759 [2018-05337]
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Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
FDA is revising the first paragraph of
the agenda for that meeting to read as
follows:
On Thursday, March 22, 2018, the
PAC and EMDAC will meet to discuss
drug development for the treatment of
children with achondroplasia (ACH).
The following topics should be
considered for discussion: Evidence
required to establish dose-response,
study design, study duration, intended
population, and endpoints. In the open
session, the committee does not intend
to discuss any individual research
programs.
FDA is also changing the meeting
procedure and closed committee
deliberations as follows:
Procedure: On March 22, 2018, from
12 p.m. to 6 p.m., the meeting is open
to the public.
Closed Committee Deliberations: On
March 22, 2018, from 8 a.m. to 11 a.m.,
the meeting will be closed to permit
committee review and discussion of
trade secret and/or confidential
commercial information.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05413 Filed 3–15–18; 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; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
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SUMMARY:
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solicits comments on revisions to Forms
FDA 3500, 3500A, and 3500B used in
the FDA Medical Products Reporting
Program.
Submit either electronic or
written comments on the collection of
information by May 15, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 15, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of May 15, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1960 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
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
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
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White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
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MedWatch: The FDA Medical Products
Reporting Program—OMB Control
Number 0910–0291—Extension
Members of the public use FDA’s
MedWatch system to report adverse
events, product problems, errors with
the use of a human medical product, or
when evidence of therapeutic failure is
suspected or identified in clinical use.
To ensure the marketing of safe and
effective products, it is critical that
postmarketing adverse outcomes and
product problems are reported for all
FDA-regulated human healthcare
products, including drugs (prescription
and nonprescription), biologics, medical
devices, dietary supplements, and other
special nutritional products (e.g. infant
formula and medical foods), and
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cosmetics. To facilitate reporting on
human medical products (except
vaccines) during their postapproval and
marketed lifetimes, three forms
(collectively known as the MedWatch
forms) are available from the Agency.
Form FDA 3500 is intended to be used
for voluntary (i.e., not mandated by law
or regulation) reporting by healthcare
professionals. Form FDA 3500B is
written in plain language and is
intended to be used for voluntary
reporting (i.e., not mandated by law or
regulation) by consumers (i.e., patients
and their caregivers). Form FDA 3500A
is used for mandatory reporting (i.e.,
required by law or regulation). 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 then take whatever action is
necessary to reduce, mitigate, or
eliminate the public’s exposure to the
risk through regulatory and public
health interventions.
Authorizing Statutes and Codified
Regulations
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 353b, 355,
360i, 360l, and 393); and the Public
Health Service Act (42 U.S.C. 262)
represent the statutory authority for the
FDA to collect mandatory adverse event
reports from regulated industry on
medical products once approved for
marketing—to monitor the safety of
drugs, biologics, medical devices, and
dietary supplements. There are no laws
or regulations mandating the postmarket reporting for medical foods,
infant formula, cosmetics, or tobacco
products, and the reporting for these
products is done voluntarily.
Requirements regarding mandatory
reporting of adverse events or product
problems have been codified in parts
310, 314, 600, and 803 (21 CFR 310,
314, 600, and 803), specifically
§§ 310.305, 314.80, 314.98, 600.80,
803.30, 803.50, 803.53, 803.56, 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 reactions for human cells,
tissues, and cellular- and tissue-based
products (HCT/Ps) has been codified in
21 CFR 1271.350.
Use of Form 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
health professionals are not required by
law or regulation to submit reports to
the Agency or the manufacturer with the
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exception of Childhood Vaccine Injury
Act of 1986 (42 U.S.C. 300aa–1). Reports
for vaccines are not submitted via
MedWatch or MedWatch forms, but are
submitted to the Vaccines Adverse
Event Reporting System (see https://
vaers.hhs.gov), 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 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 health 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 previously
received by the Agency on paper
versions of Form FDA 3500 (or Form
FDA 3500B) (by mail or fax). Currently,
electronic reports may be sent to the
Agency via an online submission route
called the Safety Reporting Portal
(https://www.safetyreporting.hhs.gov/).
In that case, Form FDA 3500 (or Form
FDA 3500B) is not used.
Form FDA 3500 may be used to report
to the Agency serious adverse events,
product problems, and 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.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM163919.pdf) or reporters
may electronically submit a report via
the MedWatch Online Voluntary
Reporting Form (https://
www.accessdata.fda.gov/scripts/
medwatch/). Reporting is supported for
drugs, non-vaccine biologicals, medical
devices, special nutritional products,
cosmetics, and non-prescription (over
the counter (OTC)) human drug
products marketed without an approved
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application. The paper form may also be
used to submit reports about tobacco
products and dietary supplements.
Electronic reports for tobacco products
and dietary supplements may be
submitted to the Agency via an online
submission route called the Safety
Reporting Portal (https://
www.safetyreporting.hhs.gov/).
Use of Form 3500B (Consumer
Voluntary Reporting)
This voluntary version of the form
may be used by consumers (i.e. patients
and their caregivers) to submit reports
not mandated by Federal law or
regulation. Individual patients or their
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 serious adverse outcomes and
other product problems associated with
human medical products, (https://
www.fda.gov/Safety/ReportaProblem/
default.htm). Since the inception of the
MedWatch program, launched in July
1993 by then FDA Commissioner David
Kessler, the program has been
promoting and facilitating voluntary
reporting by both the general 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).
On March 25, 2008, section 906 of the
Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85) amended section 502(n) of the FD&C
Act (21 U.S.C. 352) and mandated 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/safety/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 reporting via the MedWatch
process.
Since 2013, FDA has made available
Form FDA 3500B. It was proposed
during the previous authorization in
2012 and is a version of Form FDA 3500
that is tailored for consumers and
written in plain language (in
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conformance with the Plain Writing Act
of 2010 (Pub. L. 111–274), https://
www.gpo.gov/fdsys/pkg/PLAW111publ274/pdf/PLAW111publ274.pdf).
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 general public.
Form FDA 3500B may be used to report
to the Agency adverse events, product
problems, and product use errors. 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.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM349464.pdf) or electronically
submit a report via the MedWatch
Online Voluntary Reporting Form
(https://www.accessdata.fda.gov/
scripts/medwatch/). Reporting is
supported for drugs, non-vaccine
biologicals, medical devices, special
nutritional products, cosmetics, and
non-prescription OTC human drug
products marketed without an approved
application. The paper form may also be
used to submit reports about tobacco
products and dietary supplements.
Electronic reports for tobacco products
and dietary supplements may be
submitted to the Agency via an online
submission route called the Safety
Reporting Portal (https://
www.safetyreporting.hhs.gov/).
I. Use of Form FDA 3500A (Mandatory
Version)
A. Drug and Biological Products
In sections 505(b) and (j), 503B, and
704 (21 U.S.C. 355(b) and (j), 353B, and
374) of the FD&C Act, Congress has
required that important safety
information relating to all human drug
products be made available to the FDA
so that it can take appropriate action to
protect the public health when
necessary. Section 702 of the FD&C Act
(21 U.S.C. 372) authorizes
investigational powers to the FDA for
enforcement of the FD&C Act. These
statutory requirements regarding
mandatory reporting have been codified
by FDA under parts 310 and 314 (drugs)
and 600 (biological products).
Mandatory reporting of adverse
reactions for HCT/Ps has been codified
in § 1271.350.
B. OTC Monograph Drug Products and
Dietary Supplements
Section 760 of the FD&C Act provides
for mandatory safety reporting for non-
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prescription human drug products
marketed without an approved
application as described in the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act (Pub. L. 109–
462, December 22, 2006), which became
law on December 22, 2006. The law
requires manufacturers, packers, and
distributors of nonprescription, overthe-counter (OTC) human drug products
marketed without an approved
application (OTC monograph drug
products) to submit reports of adverse
experiences from domestic sources. The
law also requires reports of serious
adverse events to be submitted to FDA
by manufacturers of dietary
supplements.
C. Postmarketing Safety Reports—
Changes in Format Starting in June 2018
Current requirements specify that
postmarketing adverse experience
reports must be submitted on paper on
Form FDA Form 3500A (or the CIOMS
(Council for International Organizations
of Medical Sciences) I form for serious,
unexpected adverse experiences from a
foreign source). For the last several
years the Agency has accepted
electronic submissions in lieu of the
paper Form FDA 3500A on the
condition they are submitted in a
manner that the Agency can process,
review, and archive. On June 10, 2014,
the Agency issued a final rule entitled
‘‘Postmarketing Safety Reports for
Human Drug and Biological Products;
Electronic Submission Requirements’’
(79 FR 33072) that requires electronic
submission of all mandatory
postmarketing safety reports, including
individual case safety reports. Entities
with mandatory reporting obligations
under parts 310 and 314 (drugs) and
600 (biological products) and specified
under section 760 of the FD&C Act must
implement this rule within 1 year of the
issuance date (by June 10, 2015). For
more information see: https://
www.gpo.gov/fdsys/pkg/FR-2014-06-10/
pdf/2014-13480.pdf.
D. 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 be required to provide
assurance that such devices are not
adulterated or misbranded and to
otherwise assure its safety and
effectiveness. The Safe Medical Devices
Act of 1990 (Pub. L. 101–629), signed
into law on November 28, 1990, amends
section 519 of the FD&C Act. The
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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 Form
FDA 3500A for reporting to FDA on
medical devices. The Medical Device
User Fee and Modernization Act of 2002
(MDUFMA) (Pub. L. 107–250), signed
into law October 26, 2002, amended
section 519 of the FD&C Act. The
MDUFMA amendment (section 303)
required FDA to revise the MedWatch
forms to facilitate the reporting of
information relating to reprocessed
single-use devices, including the name
of the reprocessor and whether the
device has been reused.
II. Proposed Modification to Existing
Forms FDA 3500, 3500A, and 3500B
General changes—The proposed
modifications to Forms FDA 3500 and
3500A reflect changes that will bring the
form into conformance, since the
previous authorization in 2015, with
current regulations, rules, and
guidances.
11759
The proposed extension to Forms
FDA 3500, 3500A, and 3500B will only
have changes in the form instructions to
provide clarity of reporting. The
proposed changes are regulatory driven,
improving the Centers’ work, and
improving report processing. The
Agency welcomes comments about
translation of Form FDA 3500B
(consumer) into Spanish and other
languages.
Formatting modifications are being
proposed to several fields to enhance
the quality, utility, and clarity of the
information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Center for Biologics Evaluation and Research/Center for
Drug Evaluation and Research:
Form 3500 .................................................................
Form 3500A (§§ 310.305, 314.80, 314.98, 600.80,
1271.350).
Form 3500A (§§ 310.305 outsourcing facilities) ........
Center for Devices and Radiological Health:
Form 3500 .................................................................
Form 3500A (803) .....................................................
Center for Food Safety and Applied Nutrition:
Form 3500 .................................................................
Form 3500A ...............................................................
Center for Tobacco Products:
Form 3500 .................................................................
All Centers:
Form 3500B ...............................................................
Total ....................................................................
1
Total annual
responses
Average burden
per response
Total hours
14,727
599
1
98
14,727
58,702
0.66 (40 min) ....
1.21 ..................
9,720
71,029
50
2
100
1.21 ..................
121
5,233
2,277
1
296
5,233
673,992
0.66 (40 min) ....
1.21 ..................
3,454
815,530
1,793
1,659
1
1
1,793
1,659
0.66 (40 min) ....
1.21 ..................
1,183
2,007
39
1
39
0.66 (40 min) ....
26
13,750
1
13,750
0.46 (28 min) ....
6,325
........................
........................
........................
...........................
909,395
There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates have not
changed from the current approval.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Arthritis Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
SUMMARY:
Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05337 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The meeting will be held on
April 23, 2018, from 8 a.m. to 5 p.m.
DATES:
Food and Drug Administration
Arthritis Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
ACTION:
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FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
ADDRESSES:
[Docket No. FDA–2018–N–0976]
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Number of
responses per
respondent
Number of
respondents
FDA Center/FDA Form/21 CFR section
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FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–0976.
The docket will close on April 20, 2018.
Submit either electronic or written
comments on this public meeting by
April 20, 2018. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 20,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 20, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before April
9, 2018, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
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]]>Agencies
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11756-11759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05337]
-----------------------------------------------------------------------
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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on revisions to Forms FDA 3500, 3500A, and
3500B used in the FDA Medical Products Reporting Program.
DATES: Submit either electronic or written comments on the collection
of information by May 15, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of May 15, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1960 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 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 Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three
[[Page 11757]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-8867, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
MedWatch: The FDA Medical Products Reporting Program--OMB Control
Number 0910-0291--Extension
Members of the public use FDA's MedWatch system to report adverse
events, product problems, errors with the use of a human medical
product, or when evidence of therapeutic failure is suspected or
identified in clinical use. To ensure the marketing of safe and
effective products, it is critical that postmarketing adverse outcomes
and product problems are reported for all FDA-regulated human
healthcare products, including drugs (prescription and
nonprescription), biologics, medical devices, dietary supplements, and
other special nutritional products (e.g. infant formula and medical
foods), and cosmetics. To facilitate reporting on human medical
products (except vaccines) during their postapproval and marketed
lifetimes, three forms (collectively known as the MedWatch forms) are
available from the Agency. Form FDA 3500 is intended to be used for
voluntary (i.e., not mandated by law or regulation) reporting by
healthcare professionals. Form FDA 3500B is written in plain language
and is intended to be used for voluntary reporting (i.e., not mandated
by law or regulation) by consumers (i.e., patients and their
caregivers). Form FDA 3500A is used for mandatory reporting (i.e.,
required by law or regulation). 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 then take whatever action is necessary to reduce,
mitigate, or eliminate the public's exposure to the risk through
regulatory and public health interventions.
Authorizing Statutes and Codified Regulations
The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
353b, 355, 360i, 360l, and 393); and the Public Health Service Act (42
U.S.C. 262) represent the statutory authority for the FDA to collect
mandatory adverse event reports from regulated industry on medical
products once approved for marketing--to monitor the safety of drugs,
biologics, medical devices, and dietary supplements. There are no laws
or regulations mandating the post-market reporting for medical foods,
infant formula, cosmetics, or tobacco products, and the reporting for
these products is done voluntarily.
Requirements regarding mandatory reporting of adverse events or
product problems have been codified in parts 310, 314, 600, and 803 (21
CFR 310, 314, 600, and 803), specifically Sec. Sec. 310.305, 314.80,
314.98, 600.80, 803.30, 803.50, 803.53, 803.56, 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 reactions for human cells,
tissues, and cellular- and tissue-based products (HCT/Ps) has been
codified in 21 CFR 1271.350.
Use of Form 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 health professionals are not required by law or
regulation to submit reports to the Agency or the manufacturer with the
exception of Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1).
Reports for vaccines are not submitted via MedWatch or MedWatch forms,
but are submitted to the Vaccines Adverse Event Reporting System (see
https://vaers.hhs.gov), 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 (21 U.S.C. 342) after that product is marketed.
Therefore, the Agency depends on the voluntary reporting by health
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 previously
received by the Agency on paper versions of Form FDA 3500 (or Form FDA
3500B) (by mail or fax). Currently, electronic reports may be sent to
the Agency via an online submission route called the Safety Reporting
Portal (https://www.safetyreporting.hhs.gov/). In that case, Form FDA
3500 (or Form FDA 3500B) is not used.
Form FDA 3500 may be used to report to the Agency serious adverse
events, product problems, and 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.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may
electronically submit a report via the MedWatch Online Voluntary
Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/).
Reporting is supported for drugs, non-vaccine biologicals, medical
devices, special nutritional products, cosmetics, and non-prescription
(over the counter (OTC)) human drug products marketed without an
approved
[[Page 11758]]
application. The paper form may also be used to submit reports about
tobacco products and dietary supplements. Electronic reports for
tobacco products and dietary supplements may be submitted to the Agency
via an online submission route called the Safety Reporting Portal
(https://www.safetyreporting.hhs.gov/).
Use of Form 3500B (Consumer Voluntary Reporting)
This voluntary version of the form may be used by consumers (i.e.
patients and their caregivers) to submit reports not mandated by
Federal law or regulation. Individual patients or their 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 serious adverse outcomes and other product
problems associated with human medical products, (https://www.fda.gov/Safety/ReportaProblem/default.htm). Since the inception of the MedWatch
program, launched in July 1993 by then FDA Commissioner David Kessler,
the program has been promoting and facilitating voluntary reporting by
both the general 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).
On March 25, 2008, section 906 of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the
FD&C Act (21 U.S.C. 352) and mandated 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/safety/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 reporting via the MedWatch
process.
Since 2013, FDA has made available Form FDA 3500B. It was proposed
during the previous authorization in 2012 and is a version of Form FDA
3500 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.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
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 general
public. Form FDA 3500B may be used to report to the Agency adverse
events, product problems, and product use errors. 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.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch
Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine
biologicals, medical devices, special nutritional products, cosmetics,
and non-prescription OTC human drug products marketed without an
approved application. The paper form may also be used to submit reports
about tobacco products and dietary supplements. Electronic reports for
tobacco products and dietary supplements may be submitted to the Agency
via an online submission route called the Safety Reporting Portal
(https://www.safetyreporting.hhs.gov/).
I. Use of Form FDA 3500A (Mandatory Version)
A. Drug and Biological Products
In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and
(j), 353B, and 374) of the FD&C Act, Congress has required that
important safety information relating to all human drug products be
made available to the FDA so that it can take appropriate action to
protect the public health when necessary. Section 702 of the FD&C Act
(21 U.S.C. 372) authorizes investigational powers to the FDA for
enforcement of the FD&C Act. These statutory requirements regarding
mandatory reporting have been codified by FDA under parts 310 and 314
(drugs) and 600 (biological products). Mandatory reporting of adverse
reactions for HCT/Ps has been codified in Sec. 1271.350.
B. OTC Monograph Drug Products and Dietary Supplements
Section 760 of the FD&C Act provides for mandatory safety reporting
for non-prescription human drug products marketed without an approved
application as described in the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (Pub. L. 109-462, December 22, 2006),
which became law on December 22, 2006. The law requires manufacturers,
packers, and distributors of nonprescription, over-the-counter (OTC)
human drug products marketed without an approved application (OTC
monograph drug products) to submit reports of adverse experiences from
domestic sources. The law also requires reports of serious adverse
events to be submitted to FDA by manufacturers of dietary supplements.
C. Postmarketing Safety Reports--Changes in Format Starting in June
2018
Current requirements specify that postmarketing adverse experience
reports must be submitted on paper on Form FDA Form 3500A (or the CIOMS
(Council for International Organizations of Medical Sciences) I form
for serious, unexpected adverse experiences from a foreign source). For
the last several years the Agency has accepted electronic submissions
in lieu of the paper Form FDA 3500A on the condition they are submitted
in a manner that the Agency can process, review, and archive. On June
10, 2014, the Agency issued a final rule entitled ``Postmarketing
Safety Reports for Human Drug and Biological Products; Electronic
Submission Requirements'' (79 FR 33072) that requires electronic
submission of all mandatory postmarketing safety reports, including
individual case safety reports. Entities with mandatory reporting
obligations under parts 310 and 314 (drugs) and 600 (biological
products) and specified under section 760 of the FD&C Act must
implement this rule within 1 year of the issuance date (by June 10,
2015). For more information see: https://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.
D. 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
be required to provide assurance that such devices are not adulterated
or misbranded and to otherwise assure its safety and effectiveness. The
Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on
November 28, 1990, amends section 519 of the FD&C Act. The
[[Page 11759]]
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 Form FDA 3500A for reporting to FDA on medical
devices. The Medical Device User Fee and Modernization Act of 2002
(MDUFMA) (Pub. L. 107-250), signed into law October 26, 2002, amended
section 519 of the FD&C Act. The MDUFMA amendment (section 303)
required FDA to revise the MedWatch forms to facilitate the reporting
of information relating to reprocessed single-use devices, including
the name of the reprocessor and whether the device has been reused.
II. Proposed Modification to Existing Forms FDA 3500, 3500A, and 3500B
General changes--The proposed modifications to Forms FDA 3500 and
3500A reflect changes that will bring the form into conformance, since
the previous authorization in 2015, with current regulations, rules,
and guidances.
The proposed extension to Forms FDA 3500, 3500A, and 3500B will
only have changes in the form instructions to provide clarity of
reporting. The proposed changes are regulatory driven, improving the
Centers' work, and improving report processing. The Agency welcomes
comments about translation of Form FDA 3500B (consumer) into Spanish
and other languages.
Formatting modifications are being proposed to several fields to
enhance the quality, utility, and clarity of the information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA Center/FDA Form/21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Center for Biologics Evaluation and Research/
Center for Drug Evaluation and Research:
Form 3500.................................. 14,727 1 14,727 0.66 (40 min).......................... 9,720
Form 3500A (Sec. Sec. 310.305, 314.80, 599 98 58,702 1.21................................... 71,029
314.98, 600.80, 1271.350).
Form 3500A (Sec. Sec. 310.305 50 2 100 1.21................................... 121
outsourcing facilities).
Center for Devices and Radiological Health:
Form 3500.................................. 5,233 1 5,233 0.66 (40 min).......................... 3,454
Form 3500A (803)........................... 2,277 296 673,992 1.21................................... 815,530
Center for Food Safety and Applied Nutrition:
Form 3500.................................. 1,793 1 1,793 0.66 (40 min).......................... 1,183
Form 3500A................................. 1,659 1 1,659 1.21................................... 2,007
Center for Tobacco Products:
Form 3500.................................. 39 1 39 0.66 (40 min).......................... 26
All Centers:
Form 3500B................................. 13,750 1 13,750 0.46 (28 min).......................... 6,325
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Total.................................. .............. .............. .............. ....................................... 909,395
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates have not changed from the current approval.
Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05337 Filed 3-15-18; 8:45 am]
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