[Federal Register: November 13, 2002 (Volume 67, Number 219)]
[Notices]
[Page 68876-68877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0355]
Agency Information Collection Activities; Submission for OMB
Review; 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 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 13, 2002.
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:
Stuart Shapiro, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1223.
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.
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 of information as
follows:
Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
21 CFR Section No. of Respondents per Response Responses Response Total Hours
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810.10(d) 2 1 2 8 16
810.11(a) 1 1 1 8 8
810.12(a) through (b) 1 1 1 8 8
810.14 2 1 2 16 32
810.15(a) through (d) 2 1 2 16 32
810.15(e) 10 1 10 1 10
810.16 2 12 24 40 960
810.17 2 1 2 8 16
Total .................... .................. .............. ............ 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 voluntarily.
Section 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.
Section 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.
[[Page 68877]]
Section 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.
Section 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.
Section 810.15(a) through (d)--Based on its experience with
voluntary recalls, FDA estimates that it will take approximately two
staff days (16 hours) to notify each health professional, user
facility, or individual of the order.
Section 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.
Section 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 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).
Section 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: November 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28713 Filed 11-12-02; 8:45 am]
BILLING CODE 4160-01-S