[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:
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(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