[Federal Register: December 1, 2005 (Volume 70, Number 230)]
[Notices]               
[Page 72123-72124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de05-44]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0335]

 
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.

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

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 
January 3, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: 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 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.
    In the Federal Register of September 2, 2005 (70 FR 52397), 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\
----------------------------------------------------------------------------------------------------------------
   21 CFR                            Annual Frequency per      Total Annual         Hours per
  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)                       1                      1                    1                 8             8
 through
 (b)
----------------------------------------------------------------------------------------------------------------

[[Page 72124]]


810.14                          2                      1                    2                16            32
----------------------------------------------------------------------------------------------------------------
810.15(a)                       2                      1                    2                16            32
 through
 (d)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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 five 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 six to twelve 
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: November 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23519 Filed 11-30-05; 8:45 am]

BILLING CODE 4160-01-S