Document ID: FDA-2008-N-0631-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-02-26T05:00Z

[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Notices]               
[Page 8799-8801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe09-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0631]

 
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 March 
30, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs,

[[Page 8800]]

OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to oira_
submission@omb.eop.gov. All comments should be identified with the OMB 
control number 0910-0432. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 of information implements 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) for the medical device recall authority 
provisions. Section 518(e) of the act provides FDA with the authority 
to issue an order requiring an appropriate person, including 
manufacturers, importers, distributors, and retailers of a device, if 
FDA finds that there is reasonable probability that the device intended 
for human use would cause serious adverse health consequences or death 
to: (1) Immediately cease distribution of such device, (2) immediately 
notify health professionals and device-user facilities of the order, 
and (3) instruct such professionals and facilities to cease use of such 
device.
    Further, the provisions under section 518 (e) of the act sets out a 
three- step procedure for issuance of a mandatory device recall order 
which are: (1) 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, (2) 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 and, (3) 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 provisions 
will be used by FDA to: (1) Ensure that all devices entering the market 
are safe and effective, (2) accurately and immediately detect serious 
problems with medical devices, and (3) remove dangerous and defective 
devices from the market.
    In the Federal Register of December 19, 2008 (73 FR 77719), 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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                        No. of         Annual Frequency       Total Annual       Hours per
 21 CFR Section      Respondents         per 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-b)                       1                     1                  1                8                  8
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810.14                            2                     1                  2               16                 32
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810.15(a-c)                       2                     1                  2               12                 24
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810.15(d)                         2                     1                  2                4                  8
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810.15(e)                        10                     1                 10                1                 10
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810.16(a-b)                       2                    12                 24               40                960
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810.17(a)                         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.

                                Table 2.--Estimated Annual Recodkeeping Burden\1\
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                      No. of         Annual Frequency       Total Annual
21 CFR Section    Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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810.15(b)                       2                     1                  1                  8                  8
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 8801]]

Explanation for Burden Estimates:
    The burden estimates for tables I and II of this document are based 
on FDA's experience with voluntary recalls under part 810 of the 
regulations. FDA expects no more than two mandatory recalls per year, 
as most recalls are done voluntarily. Since the last time this 
collection of information was submitted to OMB for renewal/approval, 
there have been no mandatory recalls.

    Dated: February 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4137 Filed 2-25-09; 8:45 am]

BILLING CODE 4160-01-S