[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Notices]
[Pages 45988-45990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N-0393]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; MedWatch: FDA's Medical Product 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 the ``MedWatch: The FDA 
Medical Products Reporting Program'' forms (Form FDA 3500 (voluntary 
version) and Form FDA 3500A (mandatory version). These forms will be 
used to report to the agency about adverse events and product problems 
that occur with FDA-regulated products.

DATES: Submit written comments on the collection of information by 
September 25, 2000.

ADDRESSES: 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 Medical Products Reporting Program 
(HF-2), Food and Drug Administration, 5600 Fishers Lane, rm. 17-65, 
Rockville, MD 20857, 301-827-7240. Send one self-addressed adhesive 
label to assist that office in processing your request. Copies of the 
forms may also be obtained via the Internet at http://www.fda.gov/medwatch under ``How to Report.''
    Submit written comments on the MedWatch reporting forms, Form FDA 
3500 (voluntary) and Form FDA 3500A (mandatory), 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. Copies of

[[Page 45989]]

the MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 
3500A (mandatory) are available for public examination via the Internet 
at http://www.fda.gov/ohrms/dockets/dockets/dockets.htm or in the 
Dockets Management Branch (address above) between 9 a.m. and 4 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

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. 301), section 402 (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 or product problem 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 parts 310, 
314, 600, and 803), specifically Secs. 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 and 
product problems with all medications, devices, and biologics, 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 and product problems 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 biologics, drugs and medical 
devices, distributors, and importers.

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

    Individual health professionals are not required by law or 
regulation to submit adverse event or product problem reports to the 
agency or the manufacturer. There is one exception. The National 
Childhood Vaccine Injury Act of 1986 mandates that certain adverse 
reactions following immunization be reported by physicians to the joint 
FDA/Centers for Disease Control and Prevention Vaccine Adverse Event 
Reporting System.
    Hospitals are not required by Federal law or regulation to submit 
adverse event reports on medications. However, hospitals and other 
medical 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. Consequently, the agency is totally dependent on voluntary 
reporting by health professionals and consumers about problems with the 
use of dietary supplements.
    The voluntary version of the form is used to submit all adverse 
event and product problem reports not mandated by Federal law or 
regulation.

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

A. Drug and Biologic Products

    In sections 505(j) and 704 of the act (21 U.S.C. 374), 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 Form FDA 3500A for reporting to FDA on adverse events that occur 
with drug and biologics.

B. Medical Device Products

    Section 519 of the act (21 U.S.C. 360i) requires manufacturers, 
importers, or distributors 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 ensure that such devices are not adulterated or 
misbranded and to otherwise ensure its safety and effectiveness. 
Furthermore, the Safe Medical Device Act of 1990, signed into law on 
November 28, 1990, amends section 519 of the act. The

[[Page 45990]]

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 Form 
FDA 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. 
However, the DSHEA puts the onus on FDA to prove that a particular 
product is unsafe. Consequently, the agency is dependent totally on 
voluntary reporting by health professionals and consumers about 
problems with the use of dietary supplements. (Note: Most 
pharmaceutical manufacturers already use a one-page modified version of 
the Form FDA 3500A where section G from the back of the form is 
substituted for section D on the front of the form.)

D. Medical Device Baseline Information

    The Medical Device Reporting--Baseline form (Form FDA 3417) relates 
specifically to the individual device and must be submitted with the 
first adverse event on that device reported via Form FDA 3500A. The 
information collected includes the basis for marketing (510(k), PMA, 
etc.), product code for the device, common name, location where 
manufactured, and other identifying information. The Health Industry 
Manufacturers Association (HIMA) first commented in 1992 on the 
redundancy of information required for the Baseline form stating that 
the information is also collected by the agency through the device 
listing process (Form FDA 2892) and through Form FDA 3500A. In 1998, 
HIMA commented again and, at the request of OMB, FDA explored revising 
Form FDA 3500A to include the information required by the Baseline form 
that is not collected through the listing process.
    In discussions with OMB it was decided that FDA would not attempt 
to revise Form FDA 3500A at this time, but would proceed with 
collecting the information required by the Baseline form as a separate 
part of the device listing process especially because some of the 
information required by the current Baseline form will be collected in 
that listing as a change in the listing regulations. Because the 
collection of registration and listing information will be through 
electronic means, the agency envisions a menu option on the Internet 
site to facilitate the collection of Baseline information.
    FDA will be holding stakeholder meetings to discuss the new device 
registration and listing system and will discuss using the new device 
registration and listing system electronic process as the vehicle for 
the Baseline information collection at those meetings.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden
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                                                      Annual
    FDA Center(s) \1\ (21 CFR         No. of       Frequency per   Total Annual      Hours per      Total Hours
            Section)                Respondents      Response        Responses       Response
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CBER/CDER
  Form 3500 \2\                    16,198               1          16,198               0.5         8,099
  Form 3500A \3\ (310.305,            600             455.2       273,109               1.0       273,109
   314.80, 314.98, and 600.80)
CDRH
  Form 3500 \2\                     2,650               1           2,650               0.5         1,325
  Form 3500A \3\ (part 803)         2,046              24          49,305               1.0        49,305
CFSAN
  Form 3500 \2\                       550               1             550               0.5           275
  Form 3500A \3\ (No mandatory          0               0               0               1.0             0
   requirements)
Total Hours                                                                                       332,113
  Form 3500 \2\                                                                                     9,699
  Form 3500A \3\                                                                                  332,414
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\1\ CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), CDRH
  (Center for Devices and Radiological Health), CFSAN (Center for Food Safety and Applied Nutrition).
\2\ FDA Form 3500 is for voluntary reporting,
\3\ FDA Form 3500A is for mandatory reporting.
Note.--The figures shown in table 1 of this document are based on actual calendar year 1999 reports and
  respondents for each Center and type of report.

    As more medical products are approved by FDA and marketed, and as 
knowledge increases regarding the importance of notifying FDA when 
adverse events and product problems are observed, it is expected that 
more reports will be submitted.

    Dated: July 21, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-18944 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F