[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55919-55922]
[FR Doc No: 2011-23094]

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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.

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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 http://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,<PHONE_NUMBER><EMAIL_ADDRESS>
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

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 http://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

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 (http://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 http://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 (http://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 http://www.fda.gov/medwatch/report.htm and fillable pdf version at http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf), and
is used to report to the Agency about serious adverse events, product

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 (http://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 http://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\
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                                                     Number of                        Average
   FDA Center FDA Form (21 CFR       Number of     responses per   Total annual     burden per      Total hours
            Section)                respondents     respondent       responses       response
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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
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        Total...................  ..............  ..............  ..............  ..............         452,235
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\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]
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