80 FR 50295 - Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 160 (August 19, 2015)

The Food and Drug Administration (FDA) is announcing the revised 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 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 the 20 days. Since February 2003, FDA's costs to process the device certificates have increased; however, the export certificate fee for subsequent certificates has not changed. Because of the increase, FDA is raising the fees for subsequent certificates, from the current fee of $15 to $85, and revising the formula used to calculate the number of original and subsequent device export certificates issued. These changes are necessary to ensure that the program remains self-sustaining and to cover FDA's increased costs, which are currently being covered by appropriated funds. Further, this document explains the costs associated with the export certification program for devices.

[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50295-50297]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2817]


Medical Devices; Export Certificates; Food and Drug 
Administration 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 
revised 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 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 the 20 days. Since February 2003, FDA's costs to 
process the device certificates have increased; however, the export 
certificate fee for subsequent certificates has not changed. Because of 
the increase, FDA is raising the fees for subsequent certificates, from 
the current fee of $15 to $85, and revising the formula used to 
calculate the number of original and subsequent device export 
certificates issued. These changes are necessary to ensure that the 
program remains self-sustaining and to cover FDA's increased costs, 
which are

[[Page 50296]]

currently being covered by appropriated funds. Further, this document 
explains the costs associated with the export certification program for 
devices.

DATES: The fees described in this document for export certificates for 
devices will be effective September 1, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2817. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read comments received, go to 
http://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts and/or go to the Division of Dockets Management, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Leila M. Lawrence, Office of 
Compliance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 
20993-0002, 301-796-7400, Option 3, FAX 301-847-8129.

SUPPLEMENTARY INFORMATION:

I. Background

    The EREA became law on April 26, 1996 (Pub. L. 104-134, amended by 
Pub. L. 104-180). 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 FD&C Act) (21 U.S.C. 381(e) and 382). Section 
801(e)(4) of the FD&C 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 
sections 801(e) or 802 of the FD&C Act or other applicable requirements 
of the FD&C 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 both the fee charged per subsequent export 
certificate and how the Center for Devices and Radiological Health 
(CDRH) calculates the number of original and subsequent certificates 
issued.
    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. A subsequent notice, published in 
the Federal Register on February 11, 2003 (68 FR 6925), established 
CDRH's intent to charge the maximum fee of $175 for the first 
certificate and $15 for all subsequent certificates issued for the same 
product(s) in the same request. Since February 2003, an updated 
resource review within CDRH has identified that recoverable costs of 
the device export certifications have increased. Accordingly, the fees 
have been recalculated so that the aggregate amount of fees collected 
will meet the current and future 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 2003 (FY 03); however, the export certificate 
fee for subsequent certificates has not changed. Moreover, FDA has 
allowed multiple devices to be included in a single certificate rather 
than requiring that each device have a separate certificate for which a 
fee is charged. The increased costs in the export certification program 
for devices are attributable to two major areas: (1) The increased 
volume of requests for certificates and (2) the increase in payroll 
costs over the past 12 years. These two cost areas account for the 
major differences between FY 03 and this current year.
    The volume of requests for certificates has increased by 369 
percent since FY 1997 and 107 percent since FY 2003. Hence, the export 
certificate program staff size has increased to accommodate this 
increased volume of requests. Table 1 shows the increase in 
certificates from FY 97 to FY 14:

 Table 1--Number of Export Certificates From Fiscal Year 1997 to Fiscal
                                Year 2014
------------------------------------------------------------------------
                                                             Total
                   Fiscal year (FY)                       certificates
------------------------------------------------------------------------
FY 1997..............................................             11,140
FY 2001..............................................             23,737
FY 2003..............................................             25,236
FY 2012..............................................             49,916
FY 2013..............................................             50,612
FY 2014..............................................             52,193
------------------------------------------------------------------------

    The cost of the export certification program for devices in FY 14 
is $5,735,270 for payroll and operating expenses.
    The four recoverable cost categories for preparing and issuing 
export certificates are:
     Direct personnel for research, review, tracking, writing, 
and assembly;
     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);
     billing and collection of fees; and
     overhead and administrative support.
    As previously mentioned in this document, FDA 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. However, due to the increase in payroll and 
operating expenses, the fee for issuing subsequent certificates for the 
same product(s) in response to the same request is being raised from 
the current fee of $15 to $85. Since the inception of the export 
certification program in 1996, this is only the second increase of the 
device export certificate fee under EREA. In addition, FDA is revising 
its formula for calculating the number of original and subsequent 
certificates issued.
    The following fees will be assessed starting September 1, 2015, for 
device export certificates:

[[Page 50297]]



      Table 2--Fees for Original and Subsequent Export Certificates
------------------------------------------------------------------------
              Type of certificate                     Fee (dollars)
------------------------------------------------------------------------
Original certificates (may be multiple in                            175
 number) \1\...................................
All subsequent certificates issued for the same                       85
 product(s) in response to the same request \1\
------------------------------------------------------------------------
\1\ As calculated under formula.

    Under its formula for calculating applicable fees, CDRH has allowed 
multiple devices to be included in a single certificate rather than 
requiring that each device have a separate certificate for which a fee 
is charged. While CDRH will continue to allow multiple devices to be 
included in a single certificate, it is revising the formula by which 
the number of original device export certificates (at $175 per 
certificate) and subsequent certificates (at $85 per certificate) will 
be calculated. The number of original and subsequent device export 
certificates will be calculated using a revised formula that sets the 
maximum pages per certificate to 25 pages (the certificate page and a 
maximum of 24 pages for any attachments). Previously, the maximum 
number of pages was 50. If the request is more than 25 pages, then the 
total number of pages created by the request is divided by 25 and that 
number will be the number of original certificates that will be charged 
at $175 and the remaining number of subsequent certificates will be 
charged at $85 each. For example, if you request 15 certificates and 
each certificate has 12 attachment pages plus the certificate page that 
means each certificate is 13 pages, and your request will generate 195 
pages in all. This number of pages is divided by 25 and that equals 
7.8, which is rounded to 8. Therefore, you will be charged for 8 
original certificates at $175 each and 7 subsequent certificates at $85 
each. Please note the maximum number of attachment pages is 24 pages. 
If you have more than 24 pages you will need to split the request into 
two or more requests.

III. Request for Comments

    Although the EREA does not require FDA to 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. The Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
sections 801(e) and 802 of the FD&C Act have been approved under OMB 
control number 0910-0498.

    Dated: August 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20429 Filed 8-18-15; 8:45 am]
 BILLING CODE 4164-01-P