[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Notices]
[Pages 68876-68877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28713]


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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