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)
Food and Drug Administration
Federal Register Volume 80, Issue 160 (August 19, 2015)
| Page Range | 50295-50297 | |
| FR Document | 2015-20429 |
[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] ----------------------------------------------------------------------- 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: 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
![Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50295
UCM313794.pdf. Therefore, you should always check the disabilities or special needs. If you
6. FDA’s Refuse to Accept Policy for 510(k)s Agency’s Web site at http:// require special accommodations due to
Final Guidance, December 31, 2012, www.fda.gov/AdvisoryCommittees/ a disability, please contact Philip
http://www.fda.gov/downloads/ default.htm and scroll down to the Bautista at least 7 days in advance of the
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
appropriate advisory committee meeting meeting.
UCM315014.pdf. link, or call the advisory committee FDA is committed to the orderly
information line to learn about possible conduct of its advisory committee
Dated: August 13, 2015. modifications before coming to the meetings. Please visit our Web site at
Leslie Kux, meeting. http://www.fda.gov/
Associate Commissioner for Policy. Agenda: The committee will discuss AdvisoryCommittees/
[FR Doc. 2015–20430 Filed 8–18–15; 8:45 am] new drug application (NDA) 207988, AboutAdvisoryCommittees/
BILLING CODE 4164–01–P lesinurad oral tablets, submitted by ucm111462.htm for procedures on
Ardea Biosciences, Inc., for the public conduct during advisory
treatment of hyperuricemia associated committee meetings.
DEPARTMENT OF HEALTH AND with gout, in combination with a Notice of this meeting is given under
HUMAN SERVICES xanthine oxidase inhibitor. the Federal Advisory Committee Act (5
FDA intends to make background U.S.C. app. 2).
Food and Drug Administration material available to the public no later Dated: August 12, 2015.
[Docket No. FDA–2015–N–0001] than 2 business days before the meeting. Jill Hartzler Warner,
If FDA is unable to post the background
Associate Commissioner for Special Medical
Arthritis Advisory Committee; Notice material on its Web site prior to the Programs.
of Meeting meeting, the background material will
[FR Doc. 2015–20398 Filed 8–18–15; 8:45 am]
be made publicly available at the
AGENCY: Food and Drug Administration, location of the advisory committee BILLING CODE 4164–01–P
HHS. meeting, and the background material
ACTION: Notice. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
the meeting. Background material is HUMAN SERVICES
This notice announces a forthcoming available at http://www.fda.gov/
meeting of a public advisory committee AdvisoryCommittees/Calendar/ Food and Drug Administration
of the Food and Drug Administration default.htm. Scroll down to the
(FDA). The meeting will be open to the appropriate advisory committee meeting [Docket No. FDA–2015–N–2817]
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Name of Committee: Arthritis Medical Devices; Export Certificates;
Procedure: Interested persons may
Advisory Committee. Food and Drug Administration Export
present data, information, or views,
General Function of the Committee: Reform and Enhancement Act of 1996;
orally or in writing, on issues pending
To provide advice and Certification Fees
before the committee. Written
recommendations to the Agency on submissions may be made to the contact AGENCY: Food and Drug Administration,
FDA’s regulatory issues. person on or before October 8, 2015. HHS.
Date and Time: The meeting will be Oral presentations from the public will ACTION: Notice.
held on October 23, 2015, from 8 a.m. be scheduled between approximately 1
to 5 p.m. p.m. and 2 p.m. Those individuals SUMMARY: The Food and Drug
Location: FDA White Oak Campus, interested in making formal oral Administration (FDA) is announcing the
10903 New Hampshire Ave., Bldg. 31 presentations should notify the contact revised fees the Agency will assess for
Conference Center, the Great Room (Rm. person and submit a brief statement of issuing export certificates for devices.
1503), Silver Spring, MD 20993–0002. the general nature of the evidence or The FDA Export Reform and
Answers to commonly asked questions arguments they wish to present, the Enhancement Act of 1996 (EREA)
including information regarding special names and addresses of proposed provides that any person who exports a
accommodations due to a disability, participants, and an indication of the device may request FDA certify in
visitor parking, and transportation may approximate time requested to make writing that the exported device meets
be accessed at: http://www.fda.gov/ their presentation on or before certain specified requirements. It further
AdvisoryCommittees/ September 30, 2015. Time allotted for provides that FDA shall issue such a
AboutAdvisoryCommittees/ each presentation may be limited. If the certification within 20 days of the
ucm408555.htm. number of registrants requesting to receipt of a request for such certification
Contact Person: Philip Bautista, speak is greater than can be reasonably and that FDA may charge up to $175 for
Center for Drug Evaluation and accommodated during the scheduled each certification that is issued within
Research, Food and Drug open public hearing session, FDA may the 20 days. Since February 2003, FDA’s
Administration, 10903 New Hampshire conduct a lottery to determine the costs to process the device certificates
Ave., Bldg. 31, Rm. 2417, Silver Spring, speakers for the scheduled open public have increased; however, the export
MD 20993–0002, 301–796–9001, FAX: hearing session. The contact person will certificate fee for subsequent certificates
301–847–8533, email: AAC@ notify interested persons regarding their has not changed. Because of the
fda.hhs.gov, or FDA Advisory request to speak by October 1, 2015. increase, FDA is raising the fees for
Committee Information Line, 1–800– Persons attending FDA’s advisory subsequent certificates, from the current
tkelley on DSK3SPTVN1PROD with NOTICES
741–8138 (301–443–0572 in the committee meetings are advised that the fee of $15 to $85, and revising the
Washington, DC area). A notice in the Agency is not responsible for providing formula used to calculate the number of
Federal Register about last minute access to electrical outlets. original and subsequent device export
modifications that impact a previously FDA welcomes the attendance of the certificates issued. These changes are
announced advisory committee meeting public at its advisory committee necessary to ensure that the program
cannot always be published quickly meetings and will make every effort to remains self-sustaining and to cover
enough to provide timely notice. accommodate persons with physical FDA’s increased costs, which are
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TABLE 2—FEES FOR ORIGINAL AND SUBSEQUENT EXPORT CERTIFICATES
Type of certificate Fee (dollars)
Original certificates (may be multiple in number) 1 ............................................................................................................. 175
All subsequent certificates issued for the same product(s) in response to the same request 1 ........................................ 85
1 As calculated under formula.
Under its formula for calculating heading of this document. Received Direct Comments to OMB: Written
applicable fees, CDRH has allowed comments may be seen in the Division comments and/or suggestions regarding
multiple devices to be included in a of Dockets Management between 9 a.m. the item(s) contained in this notice,
single certificate rather than requiring and 4 p.m., Monday through Friday, and especially regarding the estimated
that each device have a separate will be posted to the docket at http:// public burden and associated response
certificate for which a fee is charged. www.regulations.gov. time, should be directed to the: Office
While CDRH will continue to allow of Management and Budget, Office of
IV. The Paperwork Reduction Act of Regulatory Affairs, OIRA_submission@
multiple devices to be included in a
single certificate, it is revising the 1995 omb.eop.gov or by fax to 202–395–6974,
formula by which the number of This notice refers to previously Attention: NIH Desk Officer.
original device export certificates (at approved collections of information. Comment Due Date: Comments
$175 per certificate) and subsequent These collections of information are regarding this information collection are
certificates (at $85 per certificate) will subject to review by the Office of best assured of having their full effect if
be calculated. The number of original Management and Budget (OMB) under received within 30-days of the date of
and subsequent device export the Paperwork Reduction Act of 1995 this publication.
certificates will be calculated using a (44 U.S.C. 3501–3520). The collections For Further Information Contact: To
revised formula that sets the maximum of information in sections 801(e) and obtain a copy of the data collection
pages per certificate to 25 pages (the 802 of the FD&C Act have been plans and instruments or request more
certificate page and a maximum of 24 approved under OMB control number information on the proposed project
pages for any attachments). Previously, 0910–0498. contact: David Sharlip, Office of
the maximum number of pages was 50. Dated: August 13, 2015.
Administrative and Management
If the request is more than 25 pages, Analysis Services, National Library of
Leslie Kux,
then the total number of pages created Medicine, Building 38A, Room B2N12,
Associate Commissioner for Policy. 8600 Rockville Pike, Bethesda, MD
by the request is divided by 25 and that
[FR Doc. 2015–20429 Filed 8–18–15; 8:45 am] 20894, or call non-toll-free number (301)
number will be the number of original
certificates that will be charged at $175 BILLING CODE 4164–01–P 402–9680, or Email your request,
and the remaining number of including your address to: sharlipd@
subsequent certificates will be charged mail.nih.gov. Formal requests for
DEPARTMENT OF HEALTH AND additional plans and instruments must
at $85 each. For example, if you request
HUMAN SERVICES be requested in writing.
15 certificates and each certificate has
12 attachment pages plus the certificate Proposed Collection: Information
National Institutes of Health Program on Clinical Trials: Maintaining
page that means each certificate is 13
pages, and your request will generate Submission for OMB Review; 30-Day a Registry and Results Databank (NLM),
195 pages in all. This number of pages Comment Request; Information 0925–0586, Expiration Date 08/31/2015,
is divided by 25 and that equals 7.8, Program on Clinical Trials: Maintaining EXTENSION, National Library of
which is rounded to 8. Therefore, you a Registry and Results Databank (NLM) Medicine (NLM), National Institutes of
will be charged for 8 original certificates Health (NIH).
at $175 each and 7 subsequent Summary: Under the provisions of Need and Use of Information
certificates at $85 each. Please note the Section 3507(a)(1)(D) of the Paperwork Collection: The National Institutes of
maximum number of attachment pages Reduction Act of 1995, the National Health operates ClinicalTrials.gov,
is 24 pages. If you have more than 24 Institutes of Health (NIH) has submitted which was established as a clinical trial
pages you will need to split the request to the Office of Management and Budget registry under section 113 of the Food
into two or more requests. (OMB) a request for review and and Drug Administration Modernization
approval of the information collection Act of 1997 (Pub. L. 105–115) and was
III. Request for Comments listed below. This proposed information expanded to include a results data bank
Although the EREA does not require collection was previously published in by Title VIII of the Food and Drug
FDA to solicit comments on the the Federal Register on June 10, 2015, Administration Amendments Act of
assessment and collection of fees for page 32968 and allowed 60-days for 2007 (FDAAA). ClinicalTrials.gov
export certificates, FDA is inviting public comment. One public comment collects registration and results
comments from interested persons in was received. The purpose of this notice information for clinical trials and other
order to have the benefit of additional is to allow an additional 30 days for types of clinical studies (e.g.,
views. public comment. The National Library observational studies and patient
Interested persons may submit either of Medicine (NLM), National Institutes registries) with the objectives of
tkelley on DSK3SPTVN1PROD with NOTICES
electronic comments regarding this of Health, may not conduct or sponsor, enhancing patient enrollment and
document to http://www.regulations.gov and the respondent is not required to providing a mechanism for tracking
or written comments to the Division of respond to, an information collection subsequent progress of clinical studies,
Dockets Management (see ADDRESSES). It that has been extended, revised, or to the benefit of public health. It is
is only necessary to send one set of implemented on or after October 1, widely used by patients, physicians,
comments. Identify comments with the 1995, unless it displays a currently valid and medical researchers; in particular
docket number found in brackets in the OMB control number. those involved in clinical research.
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Document Created: 2015-12-15 11:58:35
Document Modified: 2015-12-15 11:58:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The fees described in this document for export certificates for devices will be effective September 1, 2015. | |
| 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. | |
| FR Citation | 80 FR 50295 |
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