[Federal Register Volume 67, Number 160 (Monday, August 19, 2002)]
[Notices]
[Pages 53803-53805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20916]


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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\
------------------------------------------------------------------------
                                    Annual
                        No. of    Frequency    Total      Hours    Total
   21 CFR Section    Respondents     per       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
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)
------------------------------------------------------------------------
810.14                      2           1          2        16       32
------------------------------------------------------------------------
810.15(a) through           2           1          2        16       32
 (d)
------------------------------------------------------------------------
810.15(e)                  10           1         10         1       10
------------------------------------------------------------------------
810.16                      2          12         24        40      960
------------------------------------------------------------------------
810.17                      2           1          2         8       16
------------------------------------------------------------------------
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