[Federal Register: February 10, 2003 (Volume 68, Number 27)]
[Page 6752-6754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 6752]]



Food and Drug Administration

[Docket No. 03N-0016]

Agency Information Collection Activities; Proposed Collection; 
MedWatch: The FDA Medical Products Reporting Program; Comment Request

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the ``MedWatch: The FDA Medical Products 
Reporting Program'' forms (Form FDA 3500--voluntary version and Form 
FDA 3500A--mandatory version). These forms are currently used to report 
to the agency about adverse events, product problems, and medication 
errors that occur with FDA regulated products, including drugs, 
biologicals, medical devices, and special nutritional products.

DATES:  Submit written or electronic comments on the collection of 
information by April 11, 2003.

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.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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. Submit written requests for single copies of the revised 
MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A 
(mandatory), to MedWatch: The FDA Safety Information and Adverse Event 
Reporting Program (HFD-410), Food and Drug Administration, 5600 Fishers 
Lane, rm. 15B-18, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your request. See the 
SUPPLEMENTARY INFORMATION for electronic access to the MedWatch 
reporting forms.

Information Resources Management (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: (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, Forms FDA 3500 
and 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 medication error 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 ranging from labeling 
changes to the rare product withdrawal. 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 
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/or medication error with medications, devices, 
biologics, and special nutritional products, as well as any other 
products that are regulated by FDA, two very similar forms are used, 
Form FDA 3500 is used for voluntary (i.e., not mandated by law or 
regulation) reporting of adverse events, product problems, and 
medication errors by health 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 health 
professionals, hospitals and other user-facilities (e.g., nursing 
homes, etc.), consumers, manufacturers of biological and drug products, 
medical devices, and importers.

II. Use of the Voluntary Version (FDA Form 3500)

    The voluntary version of the form is used to submit all adverse 
event, product problems, and medication error reports not mandated by 
Federal law or regulation.
    Individual health professionals are not required by law or 
regulation to submit adverse event, product problem, or medication 
error reports to the agency or the manufacturer, with the exception of 
certain adverse reactions following immunization with vaccines as 
mandated by the National Childhood

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Vaccine Injury Act (NCVIA) of 1986. Those mandatory reports are 
submitted by physicians to the joint FDA/Centers for Disease Control 
and Prevention (CDC) 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 for pdf version) rather than 
the FDA 3500 or 3500A forms.
    Hospitals are not required by Federal law or regulation to submit 
adverse event reports, product problems, or medication errors 
associated with medications, 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 
    Manufacturers of dietary supplements do not have to prove safety or 
efficacy of their products prior to marketing, nor do they have 
mandatory requirements for reporting adverse reactions to FDA. However, 
the DSHEA puts the onus on FDA to prove that a particular product is 
unsafe. The agency is dependent on the voluntary reporting by health 
professionals and consumers of suspected adverse events associated with 
the use of dietary supplements.

III. Use of the Mandatory Version (FDA Form 3500A)

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 (21 U.S.C. 372) 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 
the FDA Form 3500A form for reporting to FDA on adverse events that 
occur with drug and biologics.
    [Note: Most pharmaceutical manufacturers already use a one-page 
modified version of the 3500A form where Section G from the back of the 
form is substituted for Section D on the front of the form.]

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 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. Furthermore, the Safe 
Medical Devices Act of 1990 (SMDA), 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 the FDA Form 3500A for reporting to FDA on 
medical devices.

C. Other Products Used in Medical Therapy

    There are no mandatory requirements for the reporting of adverse 
events or product problems with products such as dietary supplements.
    FDA estimates the burden for completing the forms for this 
collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                                  No. of    Frequency    Total Annual       Hours per      Total
         FDA Center (21 CFR Section)           Respondents     per     [chyph]Responses  [chyph]Response   Hours
Center for Biologics Evaluation and Research/  ...........  .........  ................  ...............  ......
Center for Drug Evaluation and Research
  Form 3500                                      20,074           1        20,074               0.5       10,037
  Form 3500A (Sec.  Sec.   310.305, 314.80,         600      463.86       278,315               1.0       278,31
   314.98, 600.80)                                                                                            5
Center for Devices and Radiological Health     ...........  .........  ................  ...............  ......
  Form 3500                                       3,252           1         3,252               0.5       1,626
  Form 3500A (Sec.   803)                         1,935          33        63,623               1.0       63,623
Center for Food Safety and Applied Nutrition   ...........  .........  ................  ...............  ......
  Form 3500                                         895           1           895               0.5         448
  Form 3500A (no mandatory requirements)              0           0             0               1.0           0
Total Hours                                                                                               354,04
   Form 3500                                                                                              12,111
   Form 3500A                                                                                             341,93
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    NOTE: 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 2002 reports and respondents for each Center and type of 

IV. Electronic Access

    Persons with access to the Internet may obtain the MedWatch 
reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A 
(mandatory) at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/medwatch/getforms.htm or by calling 
1-800-FDA-1088 and leaving your name and mailing address. Copies of the 
MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A 
(mandatory) are available for public examination at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/dockets.htm
 or in the Dockets

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Management Branch (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 4, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-3174 Filed 2-7-03; 8:45 am]