[Federal Register Volume 64, Number 181 (Monday, September 20, 1999)]
[Notices]
[Pages 50820-50822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; MedWatch: The FDA Medical Products Reporting 
Program

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
October 20, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Building, 725 17th St. NW., rm. 10235, Washington, DC 20503, 
Attn: Desk Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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

[[Page 50821]]

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), 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 regulatory 
action is necessary to reduce or eliminate the public's exposure to the 
risk through actions 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, 312, 314, 600, and 803 (21 CFR parts 310, 312, 
314, 600, and 803), specifically Secs. 310.305, 312.32, 312.33, 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.

I. 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 (the NCVIA) mandates that certain 
adverse events following the administration of vaccines specified in 
the NCVIA 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 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.

II. Use of the Mandatory Version (Form FDA 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, 312 and 
314 (drugs), and part 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 drugs and biologics; under Sec. 312.32, written IND 
safety report notifications may be submitted on Form FDA 3500A.

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 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 totally dependent on 
voluntary reporting by health professionals and consumers about 
problems with the use of dietary supplements.
    The agency requested comments on proposed changes to the forms 
which comprise this collection of information in the Federal Register 
of November 10, 1998 (63 FR 63064). FDA received 21 comments from 
interested parties.
    Comments were made about the estimate of the ``hours per 
response.'' One comment correctly stated that the ``estimate may be 
about right for the physical act of filling out the form itself.'' 
Because Form FDA 3500A is used for mandatory reporting subject to 
different regulations (i.e., Secs. 310.305, 312.32, 314.80, 600.80, and 
803), this estimate for reporting burden is limited to completing the 
form. Estimates of the burden placed on user-facilities, distributors, 
and manufacturers to investigate a report and compile the necessary 
information would be addressed in the final rules for those 
regulations.
    Comments on the mandatory version of the form generally addressed 
the perceived major impact such a revision would have on the 
pharmaceutical and medical device industry, particularly the financial 
burden that would result from having to both reprogram their computer 
systems to handle new data elements and produce printed copies of the 
new form. Two major reasons for not revising the form at this time were 
presented by multiple respondents as follows:

[[Page 50822]]

    (1) The medical product industry (particularly the medical 
device industry) is focused on ensuring Year 2000 compliance. To 
dedicate computer personnel to totally revamp their computer systems 
to handle the new form would not be possible at this time because of 
the impact it would have on meeting absolute deadlines; and
    (2) Given that the goal is for both the pharmaceutical and 
medical device industries to submit the majority of mandatory 
reports electronically, it would present a financial burden to 
revamp systems to accommodate a paper form that will be virtually 
obsolete in the future.
    While the comments on the proposed revisions to the voluntary form 
were mainly favorable, the agency has decided to not revise either form 
at this time. This decision reflects both concern about the financial 
burden that would be placed on FDA if the voluntary form underwent 
revision, and the availability of other avenues by which use of the 
voluntary and mandatory forms can be optimized, namely appropriate 
revision of documents related to their completion.
    Regarding voluntary reporting, updated instructions for completing 
the Form FDA 3500 were posted on the Internet on the MedWatch home page 
in December 1998, and are available by mail/fax upon request. 
Questions/comments about adverse event/product problem reporting 
received by the agency over time were used as a major focus for 
revising the instructions. This updating included such changes as 
incorporation of information designed to solicit information specific 
to special nutritional products (e.g., dietary supplements) and current 
Department of Health and Human Services names and definitions for race 
to facilitate reporting of this aspect of the medical history.
    In the same vein, an omnibus entitled ``Guidance on How to Complete 
Form FDA 3500A'' for use by user facilities, distributors, importers, 
and manufacturers for mandatory adverse event and product problem 
reporting is being drafted. Also utilizing questions/comments about 
adverse event/product problem reporting received by the agency over 
time as a major focus for revision, the guidance will be designed to 
minimize possible ambiguity and maximize the utility of Form FDA 3500A 
as a tool for soliciting important safety-related information and data. 
It is planned that this guidance will replace instructions that are 
currently available.
    As both the Forms FDA 3500 (instructions) and 3500A (guidance) can 
be updated periodically based on questions/comments from stakeholders 
and statutory/regulatory changes, changing the forms themselves is not 
seen as necessary at this point.
    At such time it is decided to repropose revisions, FDA will consult 
all interested parties for input into the design.
    FDA estimates the burden 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\ (21 CFR Section)               No. of Respondents     Per Response         Responses        Response        Total Hours
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CBER/CDER
  Form 3500\2\                                                     15,456                   1            15,456               0.5           7,728
  Form 3500A\3\ (310.305, 312.32, 314.80, 314.98, and                 410                 529.3         217,014               1           217,014
   600.80)
CDRH
  Form 3500\2\                                                      2,789                   1             2,789               0.5           1,395
  Form 3500A\3\ (part 803)                                          3,100                  30.25         93,786               1            93,786
CFSAN
  Form 3500\2\                                                        316                   1               316               0.5             158
  Form 3500A\3\ (No mandatory requirements)                             0                   0                 0               1                 0
Total Hours                                                                                                                               320,081
  Form 3500\2\                                                                                                                              9,281
  Form 3500A\3\                                                                                                                           310,800
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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\ Form FDA 3500 is for voluntary reporting.
\3\ Form FDA 3500A is for mandatory reporting.
Note.--The figures in Table 1 of this document are based on actual calendar year 1998 reporting experience. It is assumed that the number of reports
  will remain stable.

    The increase in reporting burden reflects a natural increase in the 
number of reports coming into the agency. As more medical products are 
approved by FDA and marketed, and as knowledge increases of the 
importance of notifying FDA when adverse events and product problems 
are observed, it can be expected that more reports will be submitted to 
the agency either directly (voluntary Form FDA 3500) or via the 
manufacturer/user-facility (mandatory Form FDA 3500A).

    Dated: September 7, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-24309 Filed 9-17-99; 8:45 am]
BILLING CODE 4160-01-F