[Federal Register: December 1, 2005 (Volume 70, Number 230)]
[Notices]
[Page 72123-72124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de05-44]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0335]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 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.
DATES: Fax written comments on the collection of information by
January 3, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (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 do the following: (1) Cease distribution of the device, (2)
notify health professionals and device user facilities of the order,
and (3) 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.
In the Federal Register of September 2, 2005 (70 FR 52397), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received FDA estimates the
burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Annual Frequency per Total Annual Hours per
Section No. of Respondents Response Responses Response Total Hours
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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) 1 1 1 8 8
through
(b)
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[[Page 72124]]
810.14 2 1 2 16 32
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810.15(a) 2 1 2 16 32
through
(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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Total ..................... ..................... ................... ................ 1,082
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The following burden 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 estimated annual burden is 16 hours.
Section 810.11(a)--Based on 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 8 hours to prepare this
request.
Section 810.12(a) and (b)--Based on experience in similar
situations, FDA expects that there will be only one written request for
a review of a cease distribution and notification order per year and
that it will take approximately 8 hours to prepare this request.
Section 810.14--Based upon its experience with voluntary recalls,
FDA estimates that it will take approximately 16 hours to develop a
strategy for complying with the order.
Section 810.15(a) through (d)--Based upon its experience with
voluntary recalls, FDA estimates that it will take approximately 16
hours to notify each health professional, user facility, or individual
of the order.
Section 810.15(e)--Based upon 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 that it will take them about 1
hour to do so.
Section 810.16--FDA estimates that it would take no more than 40
hours to assemble and prepare a written status report required by a
recall. The status reports are prepared by manufacturers six to twelve
times each year. Therefore, each manufacturer would spend no more than
480 hours each year preparing status reports. If there were two FDA
invoked recalls each year, the total burden hours estimated would be
960 hours each year.
Section 810.17--Based on experience with similar procedures, FDA
estimates that it would take 8 hours to draft a written request for
termination of a cease distribution and notification or mandatory
recall order.
Dated: November 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23519 Filed 11-30-05; 8:45 am]
BILLING CODE 4160-01-S