[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Pages 59775-59776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0260]


Agency Information Collection Activities; Submission for OMB 
review; Comment Request; Medical Devices; 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 information collection by 
December 3, 1999.

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 20501, Attn: 
Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

 Medical Devices; Recall Authority--21 CFR Part 810

    Section 518(e) (21 U.S.C. 360h) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321 et seq.) provides that if FDA 
finds that there is a reasonable probability that a device intended for 
human use would cause serious adverse health consequences or death, FDA 
shall issue an order requiring the appropriate person to immediately 
cease distribution of such device, immediately notify health 
professionals and device user facilities of the order, and instruct 
such professionals and facilities to cease use of the device. Under 
this statutory authority, FDA issued regulations under part 810 (21 CFR 
part 810).
    The regulation in Sec. 810.10(d) provides that FDA may require the 
person named in the cease distribution and notification order to submit 
certain information to the agency. Section 810.11(a) requires that a 
request for a regulatory hearing regarding the cease distribution and 
notification order must be submitted in writing to FDA. In lieu of a 
written request for a regulatory hearing, the person named in the cease 
distribution and notification order may submit a written request asking 
that the order be modified or vacated as provided in Sec. 810.12(a). 
Under Sec. 810.12(b), a written request for review of a cease 
distribution and notification order must identify each ground upon 
which the requestor relies in asking that the order be modified or 
vacated and address an appropriate cease distribution and notification 
strategy. A written request must also address whether the order should 
be amended to require a recall of the device that was the subject of 
the order.
    Section 810.14 states that the person named in the cease 
distribution and notification order or a mandatory recall order must 
develop a strategy for complying with the order that is appropriate for 
the individual circumstances and submit the strategy to the agency for 
review. Section 810.15(a) requires that the person named in the cease 
distribution and notification order or a mandatory recall order must 
promptly notify each health professional, user facility, consignee, or 
individual of the order, and Sec. 810.15(b) through (c) prescribes the 
contents and implementation of such notification. Section 810.15(d) 
requires the person named in the order to ensure that followup 
communications are sent to all who fail to respond to the initial 
communications. Under Sec. 810.15(e), recipients of such letters must 
follow instructions in the letter and notify consignees of the order. 
Section 810.16 requires that the person named in a cease distribution 
and notification order or a mandatory recall order submit periodic 
status reports to FDA to enable the agency to assess the person's 
progress in complying with the order. The frequency of such reports and 
the agency official to whom such reports must be submitted will be 
specified in the order. Lastly, Sec. 810.17 provides that the person 
named in a cease distribution and notification order or a mandatory 
recall order may request termination of the order by submitting a 
written request to FDA. The person submitting a request must certify 
that he or she has complied in full with all the requirements of the 
order and must include a copy of the most current status report 
submitted to the agency.
     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 learn quickly about serious problems with medical 
devices, and to remove dangerous and defective devices from the market.
     In the preamble to the final rule (61 FR 59004 at 59018, November 
20, 1996), hereinafter referred to as the November 1996 final rule, the 
agency requested comments on the information collection provisions of 
the new regulation. The 60-day comment period closed January 21, 1997. 
The agency received two comments. The comments stated that: (1) The 
information collection requirements in this regulation are redundant 
and time and resource consuming, and (2) FDA should provide for the use 
of electronic media for complying with this rule.
     FDA disagrees with the comment that the information collection 
requirements for the medical device recall authority are redundant and 
time and resource consuming. Almost all recalls are carried out under 
the voluntary recall procedures in part 7 (21 CFR part 7). As discussed 
in the November 1996 final rule, for cease distribution and 
notification orders and recall orders, FDA interprets the standard in 
Secs. 810.10(a) and 810.13 to match closely to the elements of a class 
I voluntary recall under part 7, subpart C, for which the agency has a 
long record of experiences. FDA will initiate a mandatory recall under 
section 518(e) of the act when FDA finds that there is a reasonable 
probability that a device would cause serious, adverse health 
consequences or death. A firm may initiate a voluntary recall of a 
violative device without FDA intervention;

[[Page 59776]]

however, if FDA determines that such a voluntary recall is not 
effective in remedying a violation and there remains a reasonable 
probability that the violative device would cause serious adverse 
health consequences or death, FDA will invoke the medical device recall 
authority in addition to the voluntary efforts that the manufacturer 
has already undertaken. FDA will not order a mandatory recall if a 
voluntary recall has been effective in addressing the problems.
    FDA believes that the November 1996 final rule provides sufficient 
flexibility so as to minimize the burden on those required to take 
action consistent with the determination that the device presents a 
risk of serious adverse health consequences or death. FDA expects that 
at most one or two recalls per year would be ordered that would not 
have occurred without this regulation.
    In response to the comment regarding the use of electronic media 
for complying with these provisions, the regulation for electronic 
records and electronic signatures became effective March 20, 1997. Part 
11 (21 CFR part 11) sets forth the criteria under which FDA will accept 
documents and signatures in electronic form in lieu of paper.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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810.10(d)                               2               1               2               8              16
810.11(a)                               1               1               1               8               8
810.12(a) and (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               1               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 operating and maintenance or capital costs associated with this collection of information.

    FDA developed these estimates based on its experience with the 
number of voluntary recalls received in the last 3 years and other 
similar procedures.

    Dated: October 27, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-28664 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F