[Federal Register: September 2, 2005 (Volume 70, Number 170)]
[Notices]               
[Page 52397-52399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se05-73]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0335]

 
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

[[Page 52398]]

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 medical device recall 
authority.

DATES: Submit written or electronic comments on the collection of 
information by November 1, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (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 these topics: (1) Whether the proposed collection 
of information is necessary 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 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 do the following: (1) Cease distribution of the device, (2) 
notify health professionals and device user facilities of the order, 
and (3) 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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
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                  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
----------------------------------------------------------------------------------------------------------------

[[Page 52399]]


Total                                                                                                      1,082
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The following burden 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 estimated annual burden is 16 hours.
    Section 810.11(a)--Based on 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 8 hours to prepare this 
request.
    Section 810.12(a) and (b)--Based on experience in similar 
situations, FDA expects that there will be only one written request for 
a review of a cease distribution and notification order per year and 
that it will take approximately 8 hours to prepare this request.
    Section 810.14--Based upon its experience with voluntary recalls, 
FDA estimates that it will take approximately 16 hours to develop a 
strategy for complying with the order.
    Section 810.15(a) through (d)--Based upon its experience with 
voluntary recalls, FDA estimates that it will take approximately 16 
hours to notify each health professional, user facility, or individual 
of the order.
    Section 810.15(e)--Based upon its experience with voluntary 
recalls, FDA estimates that there will be approximately 5 consignees 
per recall (10 per year) who will be required to notify their 
consignees of the order. FDA estimates that it will take them about 1 
hour to do so.
    Section 810.16--FDA estimates that it would take no more than 40 
hours to assemble and prepare a written status report required by a 
recall. 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. If there were two FDA invoked 
recalls each year, the total burden hours estimated would be 960 hours 
each year.
    Section 810.17--Based on experience with similar procedures, FDA 
estimates that it would take 8 hours to draft a written request for 
termination of a cease distribution and notification or mandatory 
recall order.

    Dated: August 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17499 Filed 9-1-05; 8:45 am]

BILLING CODE 4160-01-S