[Federal Register: February 10, 2003 (Volume 68, Number 27)]
[Notices]
[Page 6752-6754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe03-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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://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.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.
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: (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
labeling.
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
regulation).
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://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
injuries.
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\
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Annual
No. of Frequency Total Annual Hours per Total
FDA Center (21 CFR Section) Respondents per [chyph]Responses [chyph]Response Hours
Response
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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
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Total Hours 354,04
9
Form 3500 12,111
Form 3500A 341,93
8
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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
report.
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://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://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]
BILLING CODE 4160-01-S