Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program, 55919-55922 [2011-23094]
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55919
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
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.
Notice of Participation—21 CFR 12.45
(OMB Control Number 0910–0191)—
Extension
Section 12.45 (21 CFR 12.45), issued
under section 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371),
sets forth the format and procedures for
any interested person to file a petition
to participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in 21
CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry,
concerning disclosure of data and
information by participants (21 CFR
13.25). In accordance with § 12.45(e),
the presiding officer may omit a
participant’s appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses, or other for-profit groups
and institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
12.45 ....................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
4
1
Food and Drug Administration
Paperwork Reduction Act of 1995 (the
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 Form FDA 3500 and Form
FDA 3500A, and proposed consumer
version of Form FDA 3500 (known as
the MedWatch reporting form) used in
the FDA Medical Products Reporting
Program.
[Docket No. FDA–2011–N–0608]
DATES:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
ADDRESSES:
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23105 Filed 9–8–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
4
Total hours
3
12
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years.
AGENCY:
Average
burden per
response
Total annual
responses
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
SUMMARY:
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Submit either electronic or
written comments on the collection of
information by November 8, 2011.
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
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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
To ensure the marketing of safe and
effective products, postmarketing
adverse outcomes and product problems
must be reported for all FDA-regulated
human health care products, including
drugs, both prescription and over-thecounter (OTC); biologics; medical
devices; dietary supplements and other
special nutritional products (e.g., infant
formula and medical foods); and
cosmetics. In addition, FDA has
regulatory responsibility for tobacco
products and an interest in receiving
reports about adverse outcomes and
product problems for these products.
Under sections 505, 512, 513, 515,
519, and 903 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355, 357, 360b, 360c, 360e, 360i,
and 393) and section 351 of the Public
Health Service Act (42 U.S.C. 262), FDA
has the responsibility to ensure the
safety and effectiveness of drugs,
biologics, and devices. Under section
502(a) of the FD&C Act (21 U.S.C.
352(f)(2)), a drug or device is
misbranded if its labeling is false or
misleading. Under section 502(f)(1) of
the FD&C Act, it is misbranded if it fails
to bear adequate warnings, and under
section 502(j), it is misbranded if it is
dangerous to health when used as
directed in its labeling. Under section
502(t)(2) of the FD&C Act, devices are
considered to be misbranded if there has
been a failure or refusal to give required
notification or to furnish required
material or information required under
section 519. 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
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§§ 310.305, 314.80, 314.98, 600.80,
803.30, 803.50, 803.53, and 803.56, and
specified in sections 760 and 761 of the
FD&C Act. 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.
FDA regulates the safety (i.e.,
adulteration) of dietary supplements
under section 402 of the FD&C Act (21
U.S.C. 342). Dietary supplements do not
require premarket approval by FDA and
the Agency bears the burden to gather
and review evidence that a dietary
supplement may be adulterated under
section 402 of the FD&C Act after that
product is marketed. Under section
761(b)(1) of the FD&C Act (21 U.S.C.
379aa–1(b)(1)), 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.
Mandatory reporting, since 1993, has
been supplemented by voluntary
reporting by health care professionals,
their 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 (inequivalence) is
suspected or identified in clinical use.
When FDA receives this information
from either health care professionals or
patients, the report becomes data that
will be used to assess and evaluate the
risk associated with the product, and
then FDA will take whatever action is
necessary to reduce, mitigate, or
eliminate the public’s exposure to the
risk through regulatory and public
health interventions.
To implement these provisions for
reporting on human medical products
during their postapproval and marketed
lifetimes, two forms are available from
the Agency. Form FDA 3500 is used for
voluntary (i.e., not mandated by law or
regulation) reporting by health care
professionals and the public. Form FDA
3500A is used for mandatory reporting
(i.e., required by law or regulation).
Respondents to this collection of
information are health care
professionals; medical care
organizations and other user-facilities
(e.g., extended care facilities,
ambulatory surgical centers);
consumers; manufacturers of biological,
dietary supplement, and drug products
or medical devices; and importers.
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II. Use of Form FDA 3500 (Voluntary
Version)
The voluntary version of the form is
used 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 certain adverse
reactions following immunization with
vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986.
Those mandatory reports are not
submitted to FDA on the 3500 or 3500A
form but are submitted to the joint FDA/
Centers for Disease Control and
Prevention Vaccines Adverse Event
Reporting System (VAERS) on the
VAERS–1 form (see https://
vaers.hhs.gov/resources/vaers_form.pdf)
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 (21
U.S.C. 379aa–1(b)(1))), a dietary
supplement manufacturer, packer, or
distributor whose name appears on the
label of a dietary supplement marketed
in the United States is required to
submit to FDA any serious adverse
event report it receives regarding use of
the dietary supplement in the United
States. However, FDA bears the burden
to gather and review evidence that a
dietary supplement may be adulterated
under section 402 of the FD&C Act after
that product is marketed. Therefore, the
Agency depends on the voluntary
reporting by health professionals and
especially by consumers of suspected
serious adverse events and product
quality problems associated with the
use of dietary supplements.
III. Use of Form FDA 3500A
(Mandatory Version)
A. Drug and Biologic Products
In sections 505(j) and 704 (21 U.S.C.
374) of the FD&C Act, Congress has
required that important safety
information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the FD&C Act authorizes investigational
powers to FDA for enforcement of the
FD&C Act. These statutory requirements
regarding mandatory reporting have
been codified by FDA under 21 parts
310 and 314 (drugs) and 600 (biologics)
of the Code of Federal Regulations. Parts
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310, 314, and 600 mandate the use of
the FDA Form 3500A form for reporting
to FDA on adverse events that occur
with drugs and biologics. Mandatory
reporting of adverse reactions for HCT/
Ps has been codified in 21 CFR
1271.350.
The majority of the mandatory reports
for drug products, which at inception of
Form FDA 3500A’s use were received
by Agency on the paper version of Form
FDA 3500A (by mail or FAX), are now
submitted and received by the Agency
via an electronic submission route. In
that case, the Form FDA 3500A is not
used.
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B. Medical Device Products
Section 519 of the FD&C Act (21
U.S.C. 360i) requires manufacturers and
importers of devices intended for
human use to establish and maintain
records, make reports, and provide
information as the Secretary of Health
and Human Services may by regulation
reasonably require to assure that such
devices are not adulterated or
misbranded and to otherwise assure its
safety and effectiveness. The Safe
Medical Device Act of 1990, signed into
law on November 28, 1990, amends
section 519 of the FD&C Act. The
amendment requires that user facilities
such as hospitals, nursing homes,
ambulatory surgical facilities, and
outpatient treatment facilities report
deaths related to medical devices to
FDA and to the manufacturer, if known.
Serious illnesses and injuries are to be
reported to the manufacturer or to FDA
if the manufacturer is not known. These
statutory requirements regarding
mandatory reporting have been codified
by FDA under 21 CFR part 803 (part
803). Part 803 mandates the use of the
FDA Form 3500A for reporting to FDA
on medical devices. The Medical Device
User Fee and Modernization Act of
2002, Public Law 107–250, signed into
law October 26, 2002, amended section
519 of the FD&C Act. The 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.’’
C. Nonprescription Drug Products and
Dietary Supplements
Section 502(x) in the FD&C Act (21
U.S.C. 352(x)) 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
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of nonprescription (OTC) human drug
products marketed without an approved
application. The law requires reports of
serious adverse events to be submitted
to FDA by manufacturers of dietary
supplements and nonprescription drugs.
field be added to Form FDA 3500A to
request an e-mail address for the
mandatory reporter, to supplement the
phone number and mailing address
currently included on the form. This
change is proposed for fields E1 and G1.
IV. Proposed Modifications to Existing
Forms 3500 and 3500A
V. Proposed Addition of Consumer
Version of Form FDA 3500
FDA supports and encourages direct
reporting to the Agency by consumers
(patients and their caregivers) 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
health care professionals (Ref. 1). FDA
has further encouraged voluntary
reporting by requiring inclusion of the
MedWatch toll-free telephone number
or the MedWatch Internet address on all
outpatient drug prescriptions dispensed,
as mandated by section 17 of the Best
Pharmaceuticals for Children’s Act
(Pub. L. 107–109).
On March 25, 2008, section 906 of the
FDA Amendments Act amended section
502(n) of the FD&C Act 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/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 and
Form FDA 3500.
Currently, the non-health care
professional public may submit
voluntary reports using Form FDA 3500
(https://www.fda.gov/Safety/MedWatch/
HowToReport/ucm053074.htm). This
reporting form was created 20 years ago,
and modeled after an earlier version of
the Agency’s reporting form for health
care professionals. Form FDA 3500 is
provided in paper and electronic
formats (HTML version at https://
www.fda.gov/medwatch/report.htm and
fillable pdf version at https://
www.fda.gov/downloads/Safety/
MedWatch/HowToReport/
DownloadForms/ucm082725.pdf), and
is used to report to the Agency about
serious adverse events, product
A. General Changes
The proposed modifications to Form
FDA 3500 and Form FDA 3500A reflect
changes that will bring the form into
conformation, since the previous
authorization in 2008, with current
regulations, rules, and guidances.
B. Changes Proposed for Form FDA
3500
No additional fields will be added
and no fields deleted. There are no
proposed formatting changes to the
location or distribution of the fields.
Modifications are proposed to several
field labels and descriptions to better
clarify for reporters the range of
reportable products, including tobacco
products and food (e.g., food allergens
causing allergic or anaphylaxis
reactions). Descriptive text in the field
labels and instructions were modified to
permit a better understanding of data
requested. For section E, field E4, the
label ‘‘Other’’ will be renamed ‘‘Unique
Identifier #’’ in anticipation of the use
of this product information by the
Agency for specific characterization and
identification of the medical device. The
form remains a one-sided, one-page
form with instructions for use on the
reverse side and a self-addressed,
postage-paid return mailer.
C. Changes Proposed for Form FDA
3500A
Certain formatting changes are
proposed to allow mandatory reporters
to better utilize available space for data
entry and facilitate specification of the
device product’s coding. In section D,
field D2, it is proposed that the same
field be used to request the procode
(D2b) to correspond to the existing
common device name (D2a). The D4
field currently named ‘‘Other’’ will be
renamed ‘‘Unique Identifier #.’’ Section
H, currently named ‘‘Device
Manufacturers Only’’ will be renamed
‘‘Manufacturers Only.’’ Field H1 will
have the ‘‘Other’’ checkbox removed,
and field H6, renamed ‘‘Event Problem
and Evaluation Codes’’ will have patient
code and device code boxes added, as
in the existing form’s field F10. In
section G, field G5, STN # will be
relabeled BLA #. Given the need to
contact mandatory reporters in a timely
manner, the Agency proposes that a
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problems, product use errors, and
therapeutic failure (therapeutic
inequivalence). Reporting is supported
for all FDA-regulated human medical
care products, including drugs,
biologicals, medical devices, special
nutritional products, dietary
supplements, cosmetics, and
nonprescription (OTC) human drug
products marketed without an approved
application.
Qualitative assessment by social
scientists, and comments and feedback
from the public, have recognized that
Form FDA 3500 is written and
formatted at a literacy/
comprehensibility level that far exceeds
the level recommended for the general
public by health literacy experts and
does not conform to recommendations
in the Plain Writing Act of 2010 (https://
www.gpo.gov/fdsys/pkg/PLAW–
111publ274/pdf/PLAW–
111publ274.pdf).
The proposed consumer version of the
voluntary Form FDA 3500 will request
no new data from the voluntary reporter
not already included in the existing
Form FDA 3500 that is currently used
for reporting from both health care
professionals and consumers (patients).
Certain existing fields, not considered
essential data for the consumer report
but present on the standard (i.e., health
care professional) version of Form FDA
3500, have been eliminated to facilitate
and expedite consumer submissions and
reduce reporting burden. The formatting
and the plain language used is
compatible with the intent of the Plain
Writing Act and is expected to provide
non-health care professionals with a
second option to the existing Form FDA
3500 that will reduce the burden of
reporting by facilitating their
understanding of the requested data and
further clarify the voluntary reporting
process.
The proposed consumer version of
Form FDA 3500 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. The Agency
recognizes that many consumer
reporters have a preference for accessing
a copy of the voluntary reporting form
on the Internet or submitting to FDA
using an electronic version of the form.
The Agency currently supports
voluntary reporting with the forms
submitted by mail, by FAX, by
telephone via the toll free 800 number
and online at https://www.fda.gov/
medwatch/report.htm . It is the
Agency’s expectation that an approved
consumer version of the voluntary form
will be provided for consumer use by
these same channels.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
FDA Center FDA Form (21 CFR Section)
Center for Biologics Evaluation and Research/Center for
Drug Evaluation and Research:
Form 3500 ....................................................................
Form 3500A (§§ 310.305, 314.80, 314.98, and
600.80) ......................................................................
Center for Devices and Radiological Health:
Form 3500 ....................................................................
Form 3500A (§ 803) ......................................................
Center for Food Safety and Applied Nutrition:
Form 3500 ....................................................................
Form 3500A ..................................................................
Average
burden per
response
Total hours
1
28,952
0.6
17,371
599
96
57,504
1.1
63,254
4,585
1,485
1
225
4,585
334,125
0.6
1.1
2,751
367,538
297
1,039
1
1
297
1,039
0.6
1.1
178
1,143
........................
........................
........................
........................
452,235
are no capital costs or operating and maintenance costs associated with this collection of information.
VI. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Kessler, D.A., ‘‘Introducing MEDWatch:
A New Approach to Reporting Medication
and Device Adverse Effects and Product
Problems,’’ Journal of the American Medical
Association, vol. 269, pp. 2765–2768, 1993.
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Total annual
responses
28,952
Total .......................................................................
1There
Number of
responses per
respondent
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23094 Filed 9–8–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0625]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
SUMMARY:
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Fmt 4703
Sfmt 4703
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
requirements for filing objections and
requests for a hearing on a regulation or
order.
DATES: Submit either electronic or
written comments on the collection of
information by November 8, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
E:\FR\FM\09SEN1.SGM
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Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55919-55922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23094]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0608]
Agency Information Collection Activities; Proposed Collection;
Comment Request; MedWatch: The Food and Drug Administration Medical
Products Reporting Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 Form FDA 3500 and
Form FDA 3500A, and proposed consumer version of Form FDA 3500 (known
as the MedWatch reporting form) used in the FDA Medical Products
Reporting Program.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
[[Page 55920]]
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
To ensure the marketing of safe and effective products,
postmarketing adverse outcomes and product problems must be reported
for all FDA-regulated human health care products, including drugs, both
prescription and over-the-counter (OTC); biologics; medical devices;
dietary supplements and other special nutritional products (e.g.,
infant formula and medical foods); and cosmetics. In addition, FDA has
regulatory responsibility for tobacco products and an interest in
receiving reports about adverse outcomes and product problems for these
products.
Under sections 505, 512, 513, 515, 519, and 903 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355, 357, 360b,
360c, 360e, 360i, and 393) and section 351 of the Public Health Service
Act (42 U.S.C. 262), FDA has the responsibility to ensure the safety
and effectiveness of drugs, biologics, and devices. Under section
502(a) of the FD&C Act (21 U.S.C. 352(f)(2)), a drug or device is
misbranded if its labeling is false or misleading. Under section
502(f)(1) of the FD&C Act, it is misbranded if it fails to bear
adequate warnings, and under section 502(j), it is misbranded if it is
dangerous to health when used as directed in its labeling. Under
section 502(t)(2) of the FD&C Act, devices are considered to be
misbranded if there has been a failure or refusal to give required
notification or to furnish required material or information required
under section 519. 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, and
803.56, and specified in sections 760 and 761 of the FD&C Act.
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.
FDA regulates the safety (i.e., adulteration) of dietary
supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary
supplements do not require premarket approval by FDA and the Agency
bears the burden to gather and review evidence that a dietary
supplement may be adulterated under section 402 of the FD&C Act after
that product is marketed. Under section 761(b)(1) of the FD&C Act (21
U.S.C. 379aa-1(b)(1)), 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.
Mandatory reporting, since 1993, has been supplemented by voluntary
reporting by health care professionals, their 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 (inequivalence) is suspected or identified in clinical use.
When FDA receives this information from either health care
professionals or patients, the report becomes data that will be used to
assess and evaluate the risk associated with the product, and then FDA
will take whatever action is necessary to reduce, mitigate, or
eliminate the public's exposure to the risk through regulatory and
public health interventions.
To implement these provisions for reporting on human medical
products during their postapproval and marketed lifetimes, two forms
are available from the Agency. Form FDA 3500 is used for voluntary
(i.e., not mandated by law or regulation) reporting by health care
professionals and the public. Form FDA 3500A is used for mandatory
reporting (i.e., required by law or regulation).
Respondents to this collection of information are health care
professionals; medical care organizations and other user-facilities
(e.g., extended care facilities, ambulatory surgical centers);
consumers; manufacturers of biological, dietary supplement, and drug
products or medical devices; and importers.
II. Use of Form FDA 3500 (Voluntary Version)
The voluntary version of the form is used 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 certain adverse reactions
following immunization with vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986. Those mandatory reports are not
submitted to FDA on the 3500 or 3500A form but are submitted to the
joint FDA/Centers for Disease Control and Prevention Vaccines Adverse
Event Reporting System (VAERS) on the VAERS-1 form (see https://vaers.hhs.gov/resources/vaers_form.pdf)
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
(21 U.S.C. 379aa-1(b)(1))), a dietary supplement manufacturer, packer,
or distributor whose name appears on the label of a dietary supplement
marketed in the United States is required to submit to FDA any serious
adverse event report it receives regarding use of the dietary
supplement in the United States. However, FDA bears the burden to
gather and review evidence that a dietary supplement may be adulterated
under section 402 of the FD&C Act after that product is marketed.
Therefore, the Agency depends on the voluntary reporting by health
professionals and especially by consumers of suspected serious adverse
events and product quality problems associated with the use of dietary
supplements.
III. Use of Form FDA 3500A (Mandatory Version)
A. Drug and Biologic Products
In sections 505(j) and 704 (21 U.S.C. 374) of the FD&C Act,
Congress has required that important safety information relating to all
human prescription drug products be made available to FDA so that it
can take appropriate action to protect the public health when
necessary. Section 702 of the FD&C Act authorizes investigational
powers to FDA for enforcement of the FD&C Act. These statutory
requirements regarding mandatory reporting have been codified by FDA
under 21 parts 310 and 314 (drugs) and 600 (biologics) of the Code of
Federal Regulations. Parts
[[Page 55921]]
310, 314, and 600 mandate the use of the FDA Form 3500A form for
reporting to FDA on adverse events that occur with drugs and biologics.
Mandatory reporting of adverse reactions for HCT/Ps has been codified
in 21 CFR 1271.350.
The majority of the mandatory reports for drug products, which at
inception of Form FDA 3500A's use were received by Agency on the paper
version of Form FDA 3500A (by mail or FAX), are now submitted and
received by the Agency via an electronic submission route. In that
case, the Form FDA 3500A is not used.
B. Medical Device Products
Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers
and importers of devices intended for human use to establish and
maintain records, make reports, and provide information as the
Secretary of Health and Human Services may by regulation reasonably
require to assure that such devices are not adulterated or misbranded
and to otherwise assure its safety and effectiveness. The Safe Medical
Device Act of 1990, signed into law on November 28, 1990, amends
section 519 of the FD&C Act. The amendment requires that user
facilities such as hospitals, nursing homes, ambulatory surgical
facilities, and outpatient treatment facilities report deaths related
to medical devices to FDA and to the manufacturer, if known. Serious
illnesses and injuries are to be reported to the manufacturer or to FDA
if the manufacturer is not known. These statutory requirements
regarding mandatory reporting have been codified by FDA under 21 CFR
part 803 (part 803). Part 803 mandates the use of the FDA Form 3500A
for reporting to FDA on medical devices. The Medical Device User Fee
and Modernization Act of 2002, Public Law 107-250, signed into law
October 26, 2002, amended section 519 of the FD&C Act. The 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.''
C. Nonprescription Drug Products and Dietary Supplements
Section 502(x) in the FD&C Act (21 U.S.C. 352(x)) 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 (OTC) human drug products marketed
without an approved application. The law requires reports of serious
adverse events to be submitted to FDA by manufacturers of dietary
supplements and nonprescription drugs.
IV. Proposed Modifications to Existing Forms 3500 and 3500A
A. General Changes
The proposed modifications to Form FDA 3500 and Form FDA 3500A
reflect changes that will bring the form into conformation, since the
previous authorization in 2008, with current regulations, rules, and
guidances.
B. Changes Proposed for Form FDA 3500
No additional fields will be added and no fields deleted. There are
no proposed formatting changes to the location or distribution of the
fields. Modifications are proposed to several field labels and
descriptions to better clarify for reporters the range of reportable
products, including tobacco products and food (e.g., food allergens
causing allergic or anaphylaxis reactions). Descriptive text in the
field labels and instructions were modified to permit a better
understanding of data requested. For section E, field E4, the label
``Other'' will be renamed ``Unique Identifier '' in
anticipation of the use of this product information by the Agency for
specific characterization and identification of the medical device. The
form remains a one-sided, one-page form with instructions for use on
the reverse side and a self-addressed, postage-paid return mailer.
C. Changes Proposed for Form FDA 3500A
Certain formatting changes are proposed to allow mandatory
reporters to better utilize available space for data entry and
facilitate specification of the device product's coding. In section D,
field D2, it is proposed that the same field be used to request the
procode (D2b) to correspond to the existing common device name (D2a).
The D4 field currently named ``Other'' will be renamed ``Unique
Identifier .'' Section H, currently named ``Device
Manufacturers Only'' will be renamed ``Manufacturers Only.'' Field H1
will have the ``Other'' checkbox removed, and field H6, renamed ``Event
Problem and Evaluation Codes'' will have patient code and device code
boxes added, as in the existing form's field F10. In section G, field
G5, STN will be relabeled BLA . Given the need to
contact mandatory reporters in a timely manner, the Agency proposes
that a field be added to Form FDA 3500A to request an e-mail address
for the mandatory reporter, to supplement the phone number and mailing
address currently included on the form. This change is proposed for
fields E1 and G1.
V. Proposed Addition of Consumer Version of Form FDA 3500
FDA supports and encourages direct reporting to the Agency by
consumers (patients and their caregivers) 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 health
care professionals (Ref. 1). FDA has further encouraged voluntary
reporting by requiring inclusion of the MedWatch toll-free telephone
number or the MedWatch Internet address on all outpatient drug
prescriptions dispensed, as mandated by section 17 of the Best
Pharmaceuticals for Children's Act (Pub. L. 107-109).
On March 25, 2008, section 906 of the FDA Amendments Act amended
section 502(n) of the FD&C Act 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/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 and Form FDA 3500.
Currently, the non-health care professional public may submit
voluntary reports using Form FDA 3500 (https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm). This reporting form was created 20
years ago, and modeled after an earlier version of the Agency's
reporting form for health care professionals. Form FDA 3500 is provided
in paper and electronic formats (HTML version at https://www.fda.gov/medwatch/report.htm and fillable pdf version at https://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf), and
is used to report to the Agency about serious adverse events, product
[[Page 55922]]
problems, product use errors, and therapeutic failure (therapeutic
inequivalence). Reporting is supported for all FDA-regulated human
medical care products, including drugs, biologicals, medical devices,
special nutritional products, dietary supplements, cosmetics, and
nonprescription (OTC) human drug products marketed without an approved
application.
Qualitative assessment by social scientists, and comments and
feedback from the public, have recognized that Form FDA 3500 is written
and formatted at a literacy/comprehensibility level that far exceeds
the level recommended for the general public by health literacy experts
and does not conform to recommendations in the Plain Writing Act of
2010 (https://www.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
The proposed consumer version of the voluntary Form FDA 3500 will
request no new data from the voluntary reporter not already included in
the existing Form FDA 3500 that is currently used for reporting from
both health care professionals and consumers (patients). Certain
existing fields, not considered essential data for the consumer report
but present on the standard (i.e., health care professional) version of
Form FDA 3500, have been eliminated to facilitate and expedite consumer
submissions and reduce reporting burden. The formatting and the plain
language used is compatible with the intent of the Plain Writing Act
and is expected to provide non-health care professionals with a second
option to the existing Form FDA 3500 that will reduce the burden of
reporting by facilitating their understanding of the requested data and
further clarify the voluntary reporting process.
The proposed consumer version of Form FDA 3500 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. The Agency recognizes that many
consumer reporters have a preference for accessing a copy of the
voluntary reporting form on the Internet or submitting to FDA using an
electronic version of the form. The Agency currently supports voluntary
reporting with the forms submitted by mail, by FAX, by telephone via
the toll free 800 number and online at https://www.fda.gov/medwatch/report.htm . It is the Agency's expectation that an approved consumer
version of the voluntary form will be provided for consumer use by
these same channels.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDA Center FDA Form (21 CFR Number of responses per Total annual burden per Total hours
Section) respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation
and Research/Center for Drug
Evaluation and Research:
Form 3500................... 28,952 1 28,952 0.6 17,371
Form 3500A (Sec. Sec. 599 96 57,504 1.1 63,254
310.305, 314.80, 314.98,
and 600.80)................
Center for Devices and
Radiological Health:
Form 3500................... 4,585 1 4,585 0.6 2,751
Form 3500A (Sec. 803)..... 1,485 225 334,125 1.1 367,538
Center for Food Safety and
Applied Nutrition:
Form 3500................... 297 1 297 0.6 178
Form 3500A.................. 1,039 1 1,039 1.1 1,143
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 452,235
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
VI. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Kessler, D.A., ``Introducing MEDWatch: A New Approach to
Reporting Medication and Device Adverse Effects and Product
Problems,'' Journal of the American Medical Association, vol. 269,
pp. 2765-2768, 1993.
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23094 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P