Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees, 50295-50297 [2015-20429]
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6. FDA’s Refuse to Accept Policy for 510(k)s
Final Guidance, December 31, 2012,
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM315014.pdf.
Dated: August 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20430 Filed 8–18–15; 8:45 am]
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tkelley on DSK3SPTVN1PROD with NOTICES
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50295
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Dated: August 12, 2015.
Jill Hartzler Warner,
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[FR Doc. 2015–20398 Filed 8–18–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
E:\FR\FM\19AUN1.SGM
19AUN1
50296
Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
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.
You may submit comments
by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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
https://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 https://
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:
tkelley on DSK3SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:14 Aug 18, 2015
Jkt 235001
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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
Fiscal year (FY)
FY
FY
FY
FY
FY
FY
1997
2001
2003
2012
2013
2014
..........................
..........................
..........................
..........................
..........................
..........................
Total certificates
11,140
23,737
25,236
49,916
50,612
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:
E:\FR\FM\19AUN1.SGM
19AUN1
Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
50297
TABLE 2—FEES FOR ORIGINAL AND SUBSEQUENT EXPORT CERTIFICATES
Type of certificate
Fee (dollars)
Original certificates (may be multiple in number) 1 .............................................................................................................
All subsequent certificates issued for the same 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.
tkelley on DSK3SPTVN1PROD with NOTICES
175
85
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 https://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
VerDate Sep<11>2014
19:14 Aug 18, 2015
Jkt 235001
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank (NLM)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 10, 2015,
page 32968 and allowed 60-days for
public comment. One public comment
was received. The purpose of this notice
is to allow an additional 30 days for
public comment. The National Library
of Medicine (NLM), National Institutes
of Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
For Further Information Contact: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: David Sharlip, Office of
Administrative and Management
Analysis Services, National Library of
Medicine, Building 38A, Room B2N12,
8600 Rockville Pike, Bethesda, MD
20894, or call non-toll-free number (301)
402–9680, or Email your request,
including your address to: sharlipd@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank (NLM),
0925–0586, Expiration Date 08/31/2015,
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies,
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50295-50297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20429]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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
https://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
https://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 https://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 https://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
