[Federal Register Volume 68, Number 28 (Tuesday, February 11, 2003)]
[Notices]
[Pages 6925-6927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0002]


Medical Devices; Export Certificates; FDA Export Reform and 
Enhancement Act of 1996; Certification Fees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the new 
fees the agency will assess for issuing export certificates for 
devices. The FDA Export Reform and Enhancement Act of 1996 (EREA) 
provides that any person who exports a device may request that FDA 
certify in writing that the exported device meets certain specified 
requirements. It further provides that FDA shall issue such a 
certification within 20 days of the receipt of a request for such 
certification and that FDA may charge up to $175 for each certification 
that is issued within

[[Page 6926]]

the 20 days. FDA's costs to process the device certificates have 
increased since the inception of the export certification program for 
devices. Because of the increase, FDA is raising the fees for device 
export certificates accordingly. This document explains the costs 
included in the export certification program for devices. This is the 
first increase of the device export certificate fee under the EREA 
since the initial fee was established in 1996.

DATES: The fees described in this document for export certificates for 
devices will be effective March 1, 2003. Submit written or electronic 
comments by March 13, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Leila M. Craddock, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-305), Food 
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-
827-4555, ext. 110, FAX 301-594-4715.

SUPPLEMENTARY INFORMATION:

I. Background

    The EREA became law on April 26, 1996 (Public Law 104-134, amended 
by Public Law 104-180, August 6, 1996). The principal purpose of this 
law is to expedite the export of FDA regulated products, both approved 
and unapproved, through amendments to sections 801(e) and 802 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(e) and 
382). Section 801(e)(4) of the act provides that any person who exports 
a drug, animal drug, or device may request that FDA certify in writing 
that the exported drug, animal drug, or device meets the requirements 
of section 801(e) or 802 of the act, or other applicable requirements 
of the act. Upon a showing that the product meets the applicable 
requirements, the law provides that FDA shall issue export 
certification within 20 days of the receipt of a request for such 
certification. It also allows FDA to collect fees of up to $175 for 
each certificate that is issued within the 20-day period. The focus of 
this notice is on export certificates issued by the Center for Devices 
and Radiological Health (CDRH).
    The original notice on the EREA fees for export certificates was 
published in the Federal Register on November 6, 1996 (61 FR 57445), 
and became effective October 1, 1996. An updated resource review within 
CDRH has identified that recoverable costs of the device export 
certifications have increased since October 1996. Accordingly, the fees 
have been recalculated so that the aggregate amount of fees collected 
will meet the aggregate costs to issue device export certificates.

II. Agency Costs and Fees to be Assessed for Export Certificates

    The costs of the export certification program for devices have 
grown since fiscal year 1997 (FY 97), while the export certificate fee 
has not changed. The increased costs in the export certification 
program for devices are attributable to two major areas: (1) The volume 
of requests for certificates and (2) the increase in payroll costs over 
the past 6 years. These costs account for the major differences between 
FY 97 and the current year.
    The volume of requests for certificates has increased by 100 
percent since FY 97. In order to meet this increased volume of 
requests, the staff size has grown accordingly. In addition, CDRH's 
average salary has increased by 37 percent during the same time period. 
Table 1 of this document shows the increase in certificates from FY 97 
to FY 02 (the number of certificates for 2002 was estimated):

 Table 1.--Number of Export Certificates from Fiscal Year 1997 to Fiscal
                                Year 2002
------------------------------------------------------------------------
             Fiscal Year (FY)                    Total  Certificates
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FY 97.....................................  11,140
FY 98.....................................  17,107
FY 99.....................................  18,954
FY 00.....................................  21,292
FY 01.....................................  23,737
FY 02.....................................  23,000\1\
------------------------------------------------------------------------
\1\ Estimated.

    The estimated costs of the export certification program for devices 
in FY 03 are: $533,000 for payroll and $267,000 for operating expenses. 
There are four recoverable cost categories for preparing and issuing 
export certificates. They are:
    1. Direct personnel for research, review, tracking, writing, and 
assembly;
    2. Purchase of equipment and supplies used for tracking, 
processing, printing, and packaging. Recovery of the cost of the 
equipment is calculated over its useful life;
    3. Billing and collection of fees; and
    4. Overhead and administrative support.
    As mentioned previously in this document, the agency may charge up 
to $175 for each certificate. Certificates for some classes of products 
cost the agency more than $175 to prepare. Subsequent certificates 
issued for the same product(s) in response to the same request 
generally cost the agency less than $175. The fee for all subsequent 
certificates for the same product(s) issued in response to the same 
request reflects reduced agency costs for preparing those certificates.
    The following fees will be assessed starting March 1, 2003, for 
device export certificates:

       Table 2.--Fees for First and Subsequent Export Certificates
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               Type of Certificate                     Fee (dollars)
------------------------------------------------------------------------
First certificate                                  175
------------------------------------------------------------------------
All subsequent certificates issued for the same    15
 product(s) in response to the same request.
------------------------------------------------------------------------

    The fee for issuing the first export certificate for a device 
product is now at the maximum allowable amount. This fee is now 
consistent with the export certification fees assessed since FY 97 by 
all other FDA centers who provide export certification. The fees for 
issuing subsequent certificates continue to differ among the centers, 
based on varying costs. The agency expects this new fee schedule for 
device export certificates to remain constant for at least several 
years. However, if there is an increased cost to the agency in issuing 
device export certificates, the fee for subsequent certificates for 
device products may be increased in the future.

III. Request for Comments

    Although the EREA does not require that FDA solicit comments on the 
assessment and collection of fees for export certificates, FDA is 
inviting comments from interested persons in order to have the benefit 
of additional views.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two hard copies of any 
written comments, except that individuals may submit one hard copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.


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    Dated: January 30, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-3350 Filed 2-10-03; 8:45 am]
BILLING CODE 4160-01-S