[Federal Register Volume 66, Number 122 (Monday, June 25, 2001)]
[Notices]
[Pages 33710-33711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0129]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Implementation of the Biomaterials Access 
Assurance Act of 1998

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 collection of information by July 
25, 2001.

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 20503, Attn: 
Wendy Taylor, 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.

Implementation of the Biomaterials Access Assurance Act of 1998

    The Biomaterials Access Assurance Act of 1998 (BAA98) (21 U.S.C. 
1601-1606) establishes a mechanism to protect biomaterial suppliers of 
implanted medical devices from liability in civil actions. BAA98 
includes exceptions for when protection from liability is not available 
to suppliers. One of those exceptions is when a supplier acts as a 
manufacturer of the implanted device. BAA98 says that a biomaterials 
supplier may be considered a manufacturer of a medical device if the 
supplier is the subject of an FDA declaration that the supplier was 
required to register under section 510 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360) and failed to do so, or was 
required to list its device under section 520(j) of the act (21 U.S.C. 
360(j)) and failed to do so.
    BAA98 allows persons to petition FDA for a declaration that a 
biomaterials supplier should have registered its establishment or 
listed its device with FDA, and failed to do so. Petitioners are 
requested to include information about the prerequisites for filing a 
petition. This information includes the following: (1) A civil suit has 
been filed in State or Federal court alleging that an implant directly 
or indirectly caused harm; (2) the suit was filed after August 13, 
1998; and (3) the manufacturer of the implant was named as a party to 
the civil action. Petitioners are also requested to include information 
to identify the following: (1) The final product and how it is intended 
to be used, (2) the activities the supplier performs on the device, and 
(3) the name as well as type of entity or person to which the supplier 
sends the device. These draft reporting requirements are intended to 
provide FDA with sufficient information to show that the prerequisites 
for filing the petition are met and determine whether a biomaterial 
supplier should have registered its establishment or listed its device 
with FDA, and failed to do so.
    In the Federal Register of April 2, 2001 (66 FR 17562), the agency 
requested comments on the proposed collection of information. 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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                              Annual Frequency per      Total Annual
     No. of Respondents             Response              Responses       Hours per Response      Total Hours
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5                                      1                     5                    1                   5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    BAA98 became effective August 13, 1998. Up until the current date, 
no petitions for declaration have been filed with FDA. However, FDA 
believes that in future years a handful (estimated at 5) of petitioners 
may file with the agency. FDA estimates that respondents would take 
approximately 1 hour to gather the requisite information and draft a 
petition. The likely respondents to this collection of information are 
persons involved in civil actions based on harm arising from an 
implanted medical device.


[[Page 33711]]


    Dated: June 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15780 Filed 6-22-01; 8:45 am]
BILLING CODE 4160-01-S