[Federal Register Volume 66, Number 63 (Monday, April 2, 2001)]
[Notices]
[Pages 17562-17564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0129]


Medical Devices Draft Guidance for the Implementation of the 
Biomaterials Access Assurance Act of 1998; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Implementation of the 
Biomaterials Access Assurance Act of 1998.'' The Biomaterials Access 
Assurance Act of 1998 (BAA98) allows persons to petition FDA for a 
declaration stating that a biomaterials supplier should have registered 
as a medical device establishment or listed its products with FDA but 
has not done so. This draft guidance provides information that FDA 
believes should be included in the petition, the procedures FDA 
believes should be followed in submitting the petition, and the 
procedures that the Center for Devices and Radiological Health (CDRH) 
intends to adopt for addressing petitions for declaration. This 
guidance is neither final nor is it in effect at this time.

DATES: Submit written comments on the draft guidance by July 2, 2001. 
Submit written comments on the information collection requirements by 
June 1, 2001.

ADDRESSES:  Submit written requests for single copies on a 3.5" 
diskette of the draft guidance document entitled ``Implementation of 
the Biomaterials Access Assurance Act of 1998'' to the Division of 
Small Manufacturers Assistance (HFZ-220), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing your request, or fax your request to 301-443-
8818. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Harold A. Pellerite, Center for 
Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
4692, ext. 159.

SUPPLEMENTARY INFORMATION:

I. Background

    BAA98 (21 U.S.C. 1601-1606) establishes a mechanism to protect some 
biomaterials suppliers of implanted medical devices from liability in 
civil suits for harm caused by an implant. However, biomaterials 
suppliers are not protected from liability when they fail to meet 
specifications, act as a manufacturer or seller of the implanted 
devices, or have substantial economic ties to either the manufacturer 
or seller. For the purposes of BAA98, a ``biomaterials supplier'' is 
defined as an entity that directly or indirectly supplies a component 
part or raw material for use in the manufacture of an implanted medical 
device. BAA98 also provides that a biomaterials supplier may be 
considered a manufacturer of a medical device if the supplier is the 
subject of an FDA declaration that states 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), but failed to do so, or was 
required to list its device, under section 520(j) of the act (21 U.S.C. 
360(j)), but failed to do so. BAA98 allows persons to petition FDA for 
a declaration stating that a biomaterials supplier should have 
registered or listed with FDA but has not done so.
    The draft guidance discusses the prerequisites for filing a 
petition for declaration and suggests information to be included in the 
petition. The following three prerequisites must be

[[Page 17563]]

met in order to file a petition: (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 identify the final product and its 
intended use; the activities the supplier performs with respect to the 
device; and the name as well as the type of entity or person to which 
the supplier sends the device.

 II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on BAA98. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statutes and regulations.
    The agency has adopted good guidance practices (GGP's), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115; 65 FR 56468, September 19, 2000). This draft guidance document 
is issued as a Level 1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive a copy of the draft guidance entitled 
``Implementation of the Biomaterials Access Assurance Act of 1998'' via 
your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt press 1 to order a document. Enter 
the document number (1324) followed by the pound sign (#). Follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh/comp/guidance/1324.pdf.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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 before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing a notice 
of the proposed collection of information set forth below.
    With respect to the following collection of information, FDA 
invites comments on: (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.

Implementation of the Biomaterials Access Assurance Act of 1998

    BAA98 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 act and failed to do so, 
or was required to list its device under section 520(j) of the act 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.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
                                    Annual
                                  Frequency    Total      Hours    Total
       No. of Respondents            per       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
5                                       1          5         1        5
------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital 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

[[Page 17564]]

on harm arising from an implanted medical device.

V. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by July 2, 2001. 
Submit two copies of any comments, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Written comments concerning 
the information collection requirements must be received by Dockets 
Management Branch by June 1, 2001. The draft guidance and received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: March 26, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-7956 Filed 3-30-01; 8:45 am]
BILLING CODE 4160-01-S