[Federal Register: August 19, 2002 (Volume 67, Number 160)]
[Notices]
[Page 53803-53805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au02-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0355]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority
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 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
including each proposed extension of an existing information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for medical device recall authority.
DATES: Submit written or electronic comments on the collection of
information by October 18, 2002.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: 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 extension 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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary
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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.
Medical Device Recall Authority--21 CFR Part 810 (OMB Control Number
0910-0432--Extension)
This collection implements medical device recall authority
provisions under section 518(e) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360h) and part 810 (21 CFR part 810). Section
518(e) of the act gives FDA the authority to issue an order requiring
the appropriate person, including manufacturers, importers,
distributors, and retailers of a device to immediately cease
distribution of such device, to immediately notify health professionals
and device-user facilities of the order, and to instruct such
professionals and facilities to cease use of such device, if FDA finds
that there is reasonable probability that the device intended for human
use would cause serious adverse health consequences or death.
Section 518(e) of the act sets out a three-step procedure for
issuance of a mandatory device recall order. First, if there is a
reasonable probability that a device intended for human use would cause
serious, adverse health consequences or death, FDA may issue a cease
distribution and notification order requiring the appropriate person to
immediately: (a) Cease distribution of the device, (b) notify health
professionals and device user facilities of the order, and (c) instruct
those professionals and facilities to cease use of the device. Second,
FDA will provide the person named in the cease distribution and
notification order with the opportunity for an informal hearing on
whether the order should be modified, vacated, or amended to require a
mandatory recall of the device. Third, after providing the opportunity
for an informal hearing, FDA may issue a mandatory recall order if the
agency determines that such an order is necessary.
The information collected under the recall authority will be used
by FDA to ensure that all devices entering the market are safe and
effective, to accurately and immediately detect serious problems with
medical devices, and to remove dangerous and defective devices from the
market.
The respondents to this proposed collection of information are
manufacturers, importers, distributors, and retailers of medical
devices.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours Total
21 CFR Section Respondents per Annual per Hours
Response Responses Response
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810.10(d) 2 1 2 8 16
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810.11(a) 1 1 1 8 8
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810.12(a) through 1 1 1 8 8
(b)
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810.14 2 1 2 16 32
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810.15(a) through 2 1 2 16 32
(d)
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810.15(e) 10 1 10 1 10
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810.16 2 12 24 40 960
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810.17 2 1 2 8 16
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Totals 1,082
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
Explanation of Report Burden Estimate:
The following estimates are based on FDA's experience with
voluntary recalls under 21 CFR part 7. FDA expects no more than two
mandatory recalls per year, as most recalls are done voluntary.
21 CFR 810.10(d)--FDA estimates that it will take approximately 8
hours for the person named in a cease distribution and notification
order to gather and submit the information required by this section.
The total annual burden is 16 hours.
21 CFR 810.11(a)--Based on its experience in similar situations,
FDA expects that there will be only one request for a regulatory
hearing per year and that it will take approximately one staff day (8
hours) to prepare this request.
21 CFR 810.12(a) through (b)--Based on its experience in similar
situations, FDA expects that there will be only one written request for
a review of cease distribution and notification order per year and that
it will take approximately one staff day (8 hours) to prepare this
request.
21 CFR 810.14----Based on its experience with voluntary recalls,
FDA estimates that it will take approximately two staff days (16 hours)
to develop a strategy for complying with this order.
21 CFR 810.15 (a) through (d)--Based on its experience with
voluntary recalls, FDA estimates that it will take approximately 2
staff days (16 hours) to notify each health professional, user
facility, or individual of the order.
21 CFR 810.15 (e)--Based on its experience with voluntary recalls,
FDA estimates that there will be approximately five consignees per
recall (10 per year) who will be required to notify their consignees of
the order. FDA estimates it will take them about 1 hour to do so.
21 CFR 810.16--FDA estimates that it would take no more than one
staff week (40 hours) to assemble and prepare a written status report
required by a recall (Sec. 810.16). The status reports are prepared by
manufacturers 6 to 12 times each year. Therefore, each manufacturer
would spend no more than 480 hours each year preparing status reports
(40 x
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12). If there were two FDA invoked recalls each year, the total burden
hours would be estimated at 960 hours each year (480 x 2).
21 CFR 810.17--Based on its experience with similar procedures, FDA
estimates it would take one staff day (8 hours) to draft a written
request for termination of a cease distribution and notification or
mandatory recall order.
Dated: August 13, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20916 Filed 8-16-02; 8:45 am]
BILLING CODE 4160-01-S