[Federal Register: November 16, 2000 (Volume 65, Number 222)]
[Notices]
[Page 69314-69317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no00-68]
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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.
[[Page 69315]]
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.
DATES: Submit written comments on the collection of information by
December 18, 2000.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Wendy Taylor, 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 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 0910-02910)--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 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. Likewise for cosmetics, the act does not
give FDA the authority to require manufacturers to register their
cosmetic establishments, file data on ingredients, conduct safety
testing, or report cosmetic-related injuries. Only postmarket
surveillance allows FDA to assess cosmetic problems in the marketplace.
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 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, 314, 600, 606, and 803 (21 CFR parts 310, 314,
600, 606, and 803), specifically Secs. 310.305, 314.80, 314.98, 600.14,
600.80, 606.170, 606.171, 803.30, 803.50, 803.53, and 803.56.
To implement these provisions for reporting of adverse events and
product problems with human medications, devices, and biologics, as
well as any other products that are regulated by FDA, two very similar
forms are used (an exception is biologic product deviation reports).
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). New biologic
regulations Secs. 600.14 and 606.171 require that biologic product
deviation reports, which are similar to drug product problem reports,
be submitted to FDA via a different form. Reports of fatalities as a
complication of blood collection or transfusion are reported as per
Sec. 606.170.
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, and importers.
I. 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 events
following immunization be reported by health care providers to the
joint FDA/Centers for Disease Control and Prevention Vaccine Adverse
Event Reporting System (VAERS). Vaccine reporting should be submitted
on Form VAERS-1 (FDA).
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, biological product
deviation reports, and reports of fatalities as a complication of blood
collection or transfusion.
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. Likewise for cosmetics, the act does not give FDA the authority
to require manufacturers to register their cosmetic establishments,
file data on ingredients, conduct safety testing, or report cosmetic-
related injuries. Only postmarket surveillance allows FDA to assess
cosmetic problems in the marketplace. If a problem is detected, it is
up to the agency to demonstrate that the product is harmful when used
according to label directions or under customary conditions of use.
Consequently, the agency is totally dependent on voluntary reporting by
health professionals and consumers about problems with the use of
dietary supplements and cosmetics.
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 (FDA Form 3500A)
A. Drug and Biologic Products
In section 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 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.
Blood-related fatalities are reported per Sec. 606.170.
B. Medical Device Products
Section 519 of the act (21 U.S.C. 360i) requires manufacturers or
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
[[Page 69316]]
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. FDA has codified these statutory requirements regarding
mandatory reporting under 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. (Most pharmaceutical
manufacturers already use a one-page modified version of the Form FDA
3500A where section G from the back is substituted for section D on the
front of the form.)
D. Medical Device Baseline Information
The Medical Device Reporting 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 though 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 to
facilitate the collection of the remainder of Baseline information.
FDA has held stakeholder meetings and discussed the new device
registration and listing system and using the new device and listing
system electronic process as the vehicle for the Baseline information
collection at those meetings.
The agency requested comments on this proposed collection of
information in the Federal Register of July 26, 2000 (65 FR 45988).
FDA received comments from four interested parties, but some
comments raised multiple concerns.
While the comments on the proposed revisions to the form(s) were
mainly favorable, the agency has decided to not revise either form at
this time. This decision reflects several concerns. The financial
burden that would be placed on sponsors and others required to report,
and FDA if the forms 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.
One comment suggested more detailed instructions for completing the
MedWatch form. The instructions for the voluntary form 3500 were
updated and posted on the Internet in April 2000 and the instructions
for 3500A were extensively revised and posted May 2000 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/medwatch/report/instruc.htm). Regarding voluntary
reporting, updated instructions for completing the 3500 form were
posted on the MedWatch homepage in December 1998 and April 2000. They
are available by mail/fax upon request. The revisions of both the
voluntary and mandatory instructions for use were based on questions/
comments about adverse event/product problem reporting received by the
agency over time. One main revision on both forms was to include
information about reporting on reuse of medical devices labeled for
single use.
One comment suggested revising the March 1992 guidelines to
incorporate MedWatch form use. FDA published a revised guidance for
industry entitled ``Postmarketing Adverse Experience Reporting for
Human Drug and Licensed Biological Products: Clarification of What to
Report,'' in August 1997 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/1830fn1.pdf). In this guidance it states that the agency is still
considering comments received in response to the proposed Federal
Register of October 27, 1994, and recommendations recently developed by
the International Conference on Harmonization and plans to propose
additional amendments to its postmarketing safety reporting
regulations. FDA also plans to prepare a single consolidated guidance
document on this topic once the process is concluded.
One comment suggested a FDA industry-wide assessment of consistency
of MedWatch field use for both devices and drugs. At this time a formal
assessment of the completion of the forms is not planned. As stated
above, questions/comments about use of the form and reporting have been
incorporated into the revised instructions for use for both forms. This
issue can also be addressed in any new proposed regulations or guidance
documents.
One comment suggested expanding public education regarding
postmarketing events. The MedWatch Office is in the process of
developing educational materials, primarily for health professionals,
to assist in the overall effort to improve the quality of MedWatch
reports.
One comment was made about the estimate of the ``hours per
response.'' Because the 3500A is used for mandatory reporting subject
to different regulations (i.e., 21 CFR 310.305, 312.32, 314.80, 600.80,
and part 803), this estimate for reporting burden is limited to
completing the form. Estimates of the burden placed on user-facilities,
importers and manufacturers to investigate a report and compile the
necessary information would be addressed in the final rules for those
regulations.
One comment suggested further clarification of the August 1997
guidance for definitions of identifiable patient and reporter. This
topic is currently being discussed in the World Health Organization's
Council for International Organizations of Medical Sciences, Work Group
5.
One comment suggested focusing on new or unusual events and to
allow reporting of known non-serious events via line listing. This same
commenter suggested minimal data collection for known and well-
characterized cases. These comments are addressed in the August 1997
guidance for industry entitled ``Postmarketing Adverse
[[Page 69317]]
Experience Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report.''
One comment suggested adding a box to the 3500A form to require
drug manufacturers to state the date the report was forwarded to FDA.
This is currently required for medical device reporting, but not for
drugs and biologics. However, all manufacturers must report the date
received by the manufacturer on form 3500A, section G4. Many large
manufacturers have data bases that contain the date the information was
received and the date the report was sent to FDA. As a surrogate, these
two dates can be compared to see if the company is fulfilling its
requirements under the regulations. The agency can use its regulatory
discretion in deciding whether or not action is warranted in the case
of delayed reports. What is of greater concern is the failure to report
and that cannot be detected by adding this information to the form.
Given that the goal is for both 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.
One comment suggested a ``tick box for a 30-day report,'' for form
3500A. At this time there is no requirement for a 30-day report.
As both the 3500 instructions and 3500A instructions 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 \1\
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Annual
FDA center(s) (21 No. of respondents frequency per Total annual Hours per Total hours
CFR section) response responses response
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CBER/CDER\2\
Form 3500 16,198 1 16,198 0.5 8,099
Form 3500A 600 455.2 273,109 1 273,109
(310.305, 314.80,
314.98, and
600.80)
CDRH\3\
Form 3500 2,650 1 2,650 0.5 1,325
Form 3500A (part 2,046 24 49,305 1 49,305
803)
CFSAN\4\
Form 3500 550 1 550 0.5 275
Form 3500A 0 0 0 1 0
No mandatory
requirements
Total Hours 332,113
Form 3500 9,699
Form 3500A 322,414
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research.
\3\ Center for Devices and Radiological Health.
\4\ Center for Food Safety and Applied Nutrition.
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 calendar year 1999 reports and respondents.
As more medical products are approved by the 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 voluntary reports will be submitted. Conversely, with the current
plans for increasing electronic submissions it is expected that the
number of mandatory reports will decrease.
Dated: November 9, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29324 Filed 11-15-00; 8:45 am]
BILLING CODE 4160-01-F