
[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]


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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, 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 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

[[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 (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

[[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 (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]
BILLING CODE 4160-01-P


