[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Notices]
[Page 55111-55114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se08-113]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0077]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: Food and
Drug Administration 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 a
proposed collection of information 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: Fax written comments on the collection of information by October
24, 2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0291.
[[Page 55112]]
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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: Food and Drug Administration Medical Products Reporting
Program (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, 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. 341), 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, product problem or error with use of a
medication or device 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. 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 21 CFR parts 310, 314, 600, 803, and 1271,
specifically Sec. Sec. 310.305, 314.80, 314.98, 600.80, 803.30,
803.50, 803.53, 803.56, and 1271.350(a).
Two forms are available from the agency to implement these
provisions for reporting of adverse events, product problems, and
medication/device use errors for FDA regulated products such as
medications, devices, biologics, including human tissue, cell, tissue
and cellular-based products, special nutritional products, and
cosmetics, as well as any other products that are regulated by FDA.
Form FDA 3500 may be used for voluntary (i.e., not mandated by law or
regulation) reporting by healthcare 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 healthcare
professionals, hospitals and other user facilities (e.g., nursing
homes, etc.), consumers, manufacturers of biological, drug, and dietary
supplement products or medical devices, and importers.
II. Use of Form FDA 3500 (Voluntary Version)
The voluntary version of the form is used to submit all reports not
mandated by Federal law or regulation. Individual health professionals
are not required by law or regulation to submit reports to the agency
or the manufacturer, with the exception of certain adverse reactions
following immunization with vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986. Those mandatory reports are not
submitted to FDA on the 3500 or 3500A form, but are submitted to the
joint FDA/Centers for Disease Control and Prevention Vaccines Adverse
Event Reporting System (VAERS) on the VAERS-1 form. (See http://
www.vaers.hhs.gov/pdf/vaers_form.pdf.)
Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries. The DSHEA puts the responsibility on FDA to prove
that a particular product is unsafe. The agency depends on the
voluntary reporting by health professionals and consumers of suspected
adverse events associated with the use of dietary supplements.
III. Use of Form FDA 3500A (Mandatory Version)
A. Drug and Biologic Products
In sections 505(j) (21 U.S.C. 355(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), 600 (biologics) and 1271 (Human
Cells, Tissues, and Cellular and Tissue-Based Products). Parts 310,
314, and 600 mandate the use of FDA Form 3500A form for reporting to
FDA on adverse events that occur with drugs and biologics. The Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Public Law
109-462, 120 Stat. 3469) amended the act with respect to adverse event
reporting and recordkeeping for dietary supplements and non-
prescription drugs marketed without an approved application. The law
provides for the mandatory reporting to FDA of serious adverse events
for over-the-counter (OTC) drug products. The authority is 21 U.S.C.
379aa-1(a)(3), (b)(1) and/or section 761(a)(3) and (b)(1) of the act.
B. Medical Device Products
Section 519 of the act (21 U.S.C. 360i) requires manufacturers and
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 may, by regulation, reasonably require to
assure that such devices are not adulterated or misbranded and to
otherwise assure its safety and effectiveness.
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 FDA Form 3500A for reporting to FDA on
medical devices.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250) signed into law October 26, 2002, amended section
519 of the act. The amendment (section 303 of MDUFMA) required FDA to
revise the MedWatch forms to facilitate the reporting of information
relating to reprocessed single-use devices, including the name of the
reprocessor and whether the device has been reused.
C. Dietary Supplements
The Dietary Supplement and Nonprescription Drug Consumer Protection
Act amended the act with respect to adverse event reporting and
[[Page 55113]]
recordkeeping for dietary supplements and non-prescription drugs
marketed without an approved application. The law provides for the
mandatory reporting to the Food and Drug Administration of serious
adverse events for dietary supplements. The authority is 21 U.S.C.
379aa-1(a)(3), (b)(1) and/or section 761(a)(3) and (b)(1) of the act.
IV. Proposed Modifications to Forms
FDA has proposed no modification to either the Form FDA 3500 or
Form FDA 3500A at this time. The requested extension for both forms
will only result in changes in the form instructions rather than in any
content or formatting for either form. The ability to change the
instructions will allow for any and all necessary clarifications in the
use of the form and can reflect the current range of reportable
products (e.g., OTC products and dietary supplements).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
FDA Center Respondents per Response Responses Response Total Hours
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CBER/CDER
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Form 3500 23,033 1 23,033 0.6 13,820
Form 3500A 600 765 459,102 1.1 505,012
(Sec. Sec.
310.305,
314.80,
314.98, and
600.80)
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CDRH
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Form 3500 4,375 1 4,375 0.6 2,625
Form 3500A ................. ................... ................. ................ .................
(Part 803)
User 1,084 3 3,252 1.1 3,577
Facilities 80 18 1,470 1.1 1,617
Importers 2,946 48 141,405 1.1 155,545
Manufacturers ................. ................... ................. ................ 160,739
Total 3500A ................. ................... ................. ................ 163,364
Total CDRH ................. ................... ................. ................ .................
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CFSAN
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Form 3500 479 1 479 0.6 287
Form 3500A 0 0 0 1.1 0
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Form 3500 16,732
Form 3500A 665,751
Total 682,483
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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). Form
FDA 3500 is for voluntary reporting. Form FDA 3500A is for mandatory reporting. There are no capital costs or
operating and maintenance costs associated with this collection of information. (NOTE--The figures shown in
table 1 of this document are based on actual calendar year 2007 reports and respondents. There is no burden
calculation for the mandatory reporting requirements which went into effect on December 22, 2007, for dietary
supplements (CFSAN) or OTC drugs (CDER). These estimates and opportunities for public comment will be
addressed separately by FDA and will also be incorporated in subsequent requests for extension of Forms FDA
3500 and 3500A.)
In the Federal Register of February 15, 2008 (73 FR 8879), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received three comments. There were no
comments submitted concerning the Form FDA 3500, voluntary reporting
form. All comments addressed Form FDA 3500A, the mandatory reporting
form. There were no comments submitted concerning the mandatory 3500A
form that addressed questions of whether the information obtained is
necessary for the proper performance of FDA's functions or comments
about the practical utility of this information. There was one comment
about the accuracy of the burden estimate for a subset of reports
(dietary supplements). The remainder of the comments were specific
suggestions for modifications of either the content or format of
various fields to enhance clarity of information. There was also one
comment about the use of information technology to support collection.
One comment noted that there was no burden estimate offered for the
mandatory reports that would be expected for serious adverse events
associated with dietary supplement products. In addition, the comment
offered an estimate of 30 minutes to 1 hour for the time to complete,
route for approval, and submit a mandatory report for a dietary
supplement product. FDA agrees with this estimate and, for mandatory
reports, has used a 1.1 hour estimate for time to complete a report.
FDA has chosen to not attempt to estimate a reporting burden for
mandatory dietary supplement report volume, because the burden estimate
used in this request for extension of both reporting forms is based on
actual reports for the calendar year 2007 and there was no requirement
for submission of mandatory dietary supplement reports until December
22, 2007. To address PRA burden estimates for mandatory reporting
required for both dietary supplements and OTC products under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act of
2006, FDA will submit this burden estimate information under a separate
Federal Register notice process.
There were several comments suggesting a variety of changes in the
formatting of certain fields in the mandatory form, changes to existing
text, or addition of extra text. These changes were suggested to
``reduce confusion and capture additional clarifying information.'' For
example, it was suggested that more space be allotted to certain fields
to accept more
[[Page 55114]]
text or that certain text fields be modified to ask supplemental
questions of the reporter.
FDA has carefully considered each of these changes but does not
concur with making these elective changes, which are not based on any
changes in law, rule, or regulation. Because FDA encourages electronic
submission of postmarketing adverse event reports by mandatory
reporters, and the majority of mandatory reporters use the paper-based
Form FDA 3500A only for backup purposes, the agency believes that it
would be an unfair burden to manufacturers who submit electronically to
expend resources to change their electronic versions of the paper
document which would be used only in times of rare network or server
outages. FDA believes that each of these suggested elective text
changes and additions can be addressed satisfactorily with specific
clarifying information provided in the instructions section that
supplements Form FDA 3500A.
One comment suggests that FDA modify the forms to include wording
as a ``disclaimer by consumer authorizing the treating physician to
speak with a manufacturer's representative.'' FDA disagrees with the
inclusion of this type of information within the standard reporting
form and believes that this type of information is best treated as part
of other documentation maintained by the mandatory reporter.
One comment suggests that provisions be made to allow for the
inclusion of attachments with the serious adverse event report. FDA
agrees and attachments are currently permitted both as supplements to
mailed and faxed submissions. One comment acknowledged and supported
the recently announced development of a unified federal approach to
adverse event reporting, and suggested that this approach will ease the
reporting burden for both industry and FDA and indirectly benefit
consumers.
The newly revised Forms FDA 3500 and 3500A with updated
instructions, which will address several comments' concerns about
clarity, will be made available, upon OMB approval, on the FDA's
MedWatch Web site at http://www.fda.gov/medwatch/getforms.htm.
Dated: September 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22440 Filed 9-23-08; 8:45 am]
BILLING CODE 4160-01-S