[Federal Register Volume 63, Number 217 (Tuesday, November 10, 1998)]
[Notices]
[Pages 63064-63066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0393]


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 revision of two forms 
for 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 
proposed revision of two forms from ``MedWatch: The FDA Medical 
Products Reporting Program'' (MedWatch). These forms, Form FDA 3500 
(voluntary) and Form FDA 3500A (mandatory), will be used to report to 
the agency on adverse events and product problems that occur with all 
medical products regulated by FDA.
DATES:  Submit written comments on the collection of information by 
January 11, 1999.
ADDRESSES: Submit written requests for single copies of the revised 
MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A 
(mandatory), and a summary of the proposed revisions to the forms, by 
e-mail to ``[email protected]'', by fax to 301-827-7241, or by mail 
to ``MedWatch: The FDA Medical Product Reporting Program,'' Food and 
Drug Administration (HF-2), 5600 Fishers Lane, rm. 17-65, Rockville, MD 
20857 (301-827-7240). Requests by mail should include one self-
addressed adhesive label to assist that office in processing your 
request. Copies of the forms and the summary of the changes may also be 
obtained via Internet at ``http://www.fda.gov/medwatch'' under ``How to 
Report''.
    Submit written comments on the revised MedWatch reporting forms to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:  Mark L. Pincus, Office of Information 
Resources Management (HFA-80), 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 revision 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 listed below.
    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--Revision)

    Under sections 505, 507, 512, 513, 515, and 903 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 357, 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 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 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 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 (FDA Form 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 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 (CDC) Vaccine Adverse Event 
Reporting System (VAERS).

[[Page 63065]]

    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 of 1994 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.
    Experience over the past 5 years has revealed the need to modify 
the voluntary form to better utilize the available space and to better 
query reporters for information specific to dietary supplements and 
medication quality problems.

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

A. Drug and Biologic Products

    In section 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 part 600 (biologics) of the Code of Federal Regulations. 
Parts 310, 314, and 600 mandate the use of the FDA Form 3500A for 
reporting to FDA on adverse events that occur with drugs 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 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 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. 
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 mandatory form has been modified to incorporate some new data 
elements and to allow drug and biologic manufacturers to use only the 
front page rather than the full two-page form. (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.)

IV. Estimated Reporting Burden

    FDA estimates the burden for completing the forms for this 
collection of information as follows:

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                                                   Annual Frequency     Total Annual       Hours per
  FDA Center(s)1 and Forms (with applicable 21 CFR Section)   No. of Respondents     per Response         Responses        Response        Total Hours
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CBER/CDER
  Form 35002                                                       16,008                   1            16,008               0.5           8,004
  Form 3500A3 (Secs.  310.305, 314.80, 314.98, and 600.80)            410                 573.9         235,304               1.0         235,304
CDRH
  Form 35002                                                        2,353                   1             2,353               0.5           1,176.5
  Form 3500A3 (Sec.  803)                                           3,116                  24.8          77,337               1.0          77,337
CFSAN
  Form 35002                                                          237                   1               237               0.5             118.5
  Form 3500A3 (no mandatory requirements)                               0                   0                 0               1.0               0
Total Hours                                                                                                                               321,940
  Form 35002                                                                                                                                9,299
  Form 3500A3                                                                                                                             312,641
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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), and CFSAN (Center for Food Safety and Applied Nutrition).
\2\ FDA Form 3500 is for voluntary reporting.
\3\ FDA Form 3500A is for mandatory reporting.

The figures shown in Table 1 of this document are based on actual 
number of calendar year 1997 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.

V. Request for Comments

    Interested persons may, on or before January 11, 1999, submit 
written

[[Page 63066]]

comments to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments and copies 
of the revised MedWatch reporting forms, Form FDA 3500 (voluntary) and 
Form FDA 3500A (mandatory), may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: October 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30007 Filed 11-9-98; 8:45 am]
BILLING CODE 4160-01-F