Document ID: FDA-2008-N-0631-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
Posted Date: 2008-12-19T05:00Z

[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]               
[Page 77719-77721]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de08-106]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Recall Authority

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 collection of 
information, 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 February 17, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether

[[Page 77720]]

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                          Annual Frequency per     Total Annual        Hours per
  21 CFR Section     No. of Respondents         Response             Responses          Response     Total Hours
----------------------------------------------------------------------------------------------------------------
810.10(d)                              2                     1                   2                8           16
----------------------------------------------------------------------------------------------------------------
810.11(a)                              1                     1                   1                8            8
----------------------------------------------------------------------------------------------------------------
810.12(a-b)                            1                     1                   1                8            8
----------------------------------------------------------------------------------------------------------------
810.14                                 2                     1                   2               16           32
----------------------------------------------------------------------------------------------------------------
810.15(a-c)                            2                     1                   2               12           24
----------------------------------------------------------------------------------------------------------------
810.15(d)                              2                     1                   2                4            8
----------------------------------------------------------------------------------------------------------------
810.15(e)                             10                     1                  10                1           10
----------------------------------------------------------------------------------------------------------------
810.16(a-b)                            2                    12                  24               40          960
----------------------------------------------------------------------------------------------------------------
810.17(a)                              2                     1                   2                8           16
----------------------------------------------------------------------------------------------------------------
Total               ....................  ....................  ..................  ...............        1,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

Explanation for Burden Estimates:
    The burden estimates for Tables I and II 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

[[Page 77721]]

    Dated: December 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30280 Filed 12-18-08; 8:45 am]

BILLING CODE 4160-01-S