[Federal Register: December 27, 2004 (Volume 69, Number 247)]
[Page 77256-77258]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0535]

Agency Information Collection Activities; Proposed Collection;
Comment Request; MedWatch: 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, (also known as MedWatch reporting forms). These forms
are currently used to report to the agency about adverse events,
product problems and medication/device use errors that occur with FDA
regulated products, including drugs, biologicals, medical devices,
special nutritional products, and cosmetics.

DATES: Submit written or electronic comments on the collection of
information by February 25, 2005.

ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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 20857. All comments should be identified with the docket
number found in brackets in the heading of this document. Copies of
Form FDA 3500 and Form FDA 3500A are available for public examination

[[Page 77257]]

Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets or in the Division of

Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday. Submit written requests for single copies of the
revised reporting forms, Form FDA 3500 and Form FDA 3500A to MedWatch:
FDA Safety Information and Adverse Event Reporting Program (HFD-410),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.


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: FDA Medical Products Reporting Program, Form FDA 3500 and
Form FDA 3500A--(OMB Control Number 0910-0291)--Extension

    Under sections 505, 512, 513, 515, and 903 of the Federal Food,
Drug, and Cosmetic Act (the act); (21 U.S.C. 355, 360b, 360c, 360e, 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 act (21
U.S.C. 352(a)), a drug or device is misbranded if its labeling is false
or misleading. Under section 502(f)(1) of the 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
    Under section 4 of the Dietary Supplement Health and Education Act
of 1994 (the DSHEA) (21 U.S.C. 341), section 402 of the act (21 U.S.C
342) is amended so that FDA must bear the burden of proof to show a
dietary supplement is unsafe.
    To carry out its responsibilities, the agency needs to be informed
whenever an adverse event, product problem or error with use of a
medication or device occurs. Only if FDA is provided with such
information will the agency be able to evaluate the risk, if any,
associated with the product, and take whatever action is necessary to
reduce or eliminate the public's exposure to the risk through
regulatory action. To ensure the marketing of safe and effective
products, certain adverse events must be reported. Requirements
regarding mandatory reporting of adverse events or product problems
have been codified in parts 310, 314, 600, and 803 (21 CFR parts 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.
    To implement these provisions for reporting of adverse events,
product problems and medication/device use errors for FDA regulated
products such as medications, devices, biologics, special nutritional
products, and cosmetics, as well as any other products that are
regulated by FDA, two forms are available from the agency. Form FDA
3500 may be used for voluntary (i.e., not mandated by law or
regulation) reporting by healthcare professionals and the public. Form
FDA 3500A is used for mandatory reporting (i.e., required by law or
    Respondents to this collection of information are healthcare
professionals, hospitals and other user-facilities (e.g., nursing
homes, etc.), consumers, manufacturers of biological 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.vaers.org/pdf/vaers_for.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.
    Manufacturers of dietary supplements do not have mandatory
requirements for reporting adverse reactions to FDA. The DSHEA puts the
responsibility on FDA to prove that a particular product is unsafe. The
agency depends on the voluntary reporting by health professionals and
consumers of suspected adverse events 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 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 act authorizes investigational powers to FDA for enforcement
of the act. These statutory requirements regarding mandatory reporting
have been codified by FDA under parts 310 and 314 (drugs) and 600
(biologics). Parts 310, 314, and 600 mandate the use of FDA Form 3500A
form for reporting to FDA on adverse events that occur with drugs and

B. Medical Device Products

    Section 519 of the act (21 U.S.C. 360i) requires manufacturers and
importers, of devices intended for human use to

[[Page 77258]]

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 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 part 803.
Part 803 mandates the use of FDA Form 3500A for reporting to FDA on
medical devices.
    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA),
Public Law 107-250, signed into law October 26, 2002, amended section
519 of the act. The amendment (section 303 of MDUFMA) 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.''

IV. Proposed Modifications to Forms

    The proposed modifications to Form FDA 3500 and Form FDA 3500A
reflect changes that will bring the form into conformation with current
regulations, rules, and guidances. Modifications were also made to
better reflect the range of reportable products and language was
changed slightly to provide clarity. The changes should allow reporters
to better utilize available space for data entry and offer voluntary
reporters the opportunity to better characterize the suspected adverse
event, product problem or error and provide better quality safety-
related data for agency evaluation.
    In the proposed modification to current section D, Suspect Medical
Device, the agency has relettered the form section and modified the
formatting slightly, moving two of the data elements (``Device
available for evaluation'' and ``Concomitant medical products'') to
adjacent lettered sections on the form in order to improve the
utilization of available space and allow for information on non-device
products to share these data fields. The agency believes that these
changes are compatible with the mandatory reporting instructions for
devices (Sec.  803.33) and will allow mandatory reporters to continue
to meet their reporting requirements.
    FDA estimates the burden for completing the forms for this
collection of information as follows:

                                   Table 1.--ESTIMATED ANNUAL REPORTING BURDEN
                                                           Annual        Total
      FDA Center/21 CFR Section            No. of       Frequency per    Annual      Hours per      Total Hours
                                         Respondents      Response     Responses     Response
CBER/CDER                                      22,955               1    22,955         0.6               13,773
Form 3500
Form 3500A (Sec.  Sec.   310.305,                 600           579.9   347,940         1.1              382,734
 314.80, 314.98, 600.80)
CDRH                                            3,433               1     3,433         0.6                2,060
Form 3500
Form 3500A (Part 803)                           1,935              33    63,623         1.0               63,623
CFSAN                                             847               1       847         0.6                  508
Form 3500
Form 3500A (No Mandatory                            0               0         0         0                      0
Total Hours                            ..............  ..............  .........  ..............         462,698
Form 3500                              ..............  ..............  .........  ..............          16,341
Form 3500A                             ..............  ..............  .........  ..............         446,357
(NOTE: CBER = Center for Biologics Evaluation and Research; CDER = Center for Drug Evaluation and Research; CDRH
  = Center for Devices and Radiological Health; and CFSAN = Center for Food Safety and Applied Nutrition). FDA
  Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory reporting).

    The figures shown in table 1 of this document are based on actual
fiscal year 2003 reports and respondents for each center and type of

    Dated: December 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28138 Filed 12-23-04; 8:45 am]