[Federal Register Volume 72, Number 204 (Tuesday, October 23, 2007)]
[Notices]
[Pages 60023-60025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0401]
Guidance for Industry, Food and Drug Administration, and Foreign
Governments; Fiscal Year 2008 Medical Device User Fee Small Business
Qualification and Certification; 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 guidance entitled ``FY 2008 Medical Device User Fee
Small Business Qualification and Certification.'' This guidance
explains how a business headquartered in the United States or
headquartered in a foreign nation may respectively qualify as ``small
business'' under the medical device user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the act). A ``small business'' may pay
certain medical device user fees at a substantial discount from the
standard (full) fee rates and may obtain a one-time fee waiver for its
first premarket application (a premarket approval application (PMA),
biologics license application (BLA), product development protocol
(PDP), or premarket report (PMR)).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``FY 2008 Medical Device User Fee Small Business
Qualification and Certification'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
[[Page 60024]]
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.
Identify comments with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Joseph V. Puleo, Center for Devices
and Radiological Health (HFZ-220), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3150, ext. 116, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
``FY 2008 Medical Device User Fee Small Business Qualification and
Certification'' explains how a business headquartered in the United
States or headquartered in a foreign nation may qualify as ``small
business'' under the medical device user fee provisions of the act (21
U.S.C. 301). A ``small business'' may pay certain medical device user
fees at a substantial discount from the standard (full) fee rates and
may obtain a one-time fee waiver for its first premarket application (a
PMA, BLA, PDP, or PMR). The following fees apply for fiscal year (FY)
2008:
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FY 2008
Application Type -------------------------------------------------
Standard Fee Small Business
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Premarket application $185,000 $46,250
(PMA, BLA, PDP, or
PMR)
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Panel-track PMA $138,750 $34,688
supplement
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BLA efficacy $185,000 $46,250
supplement
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180-day PMA supplement $27,750 $6,938
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Real-time PMA $12,950 $3,238
supplement
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510(k) premarket $3,404 $1,702
notification
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30-day notice $2,960 $1,480
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513(g) request $2,498 $1,249
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Periodic reporting on $6,475 $1,619
a class III device
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Establishment
registration $1,706
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To qualify as a ``small business,'' the business must have ``gross
receipts or sales'' of no more than $100 million in the most-recent tax
year, including the ``gross receipts or sales'' of all of the business'
affiliates (see sections 738(d)(2)(A) and (e)(2)(A) of the act (21
U.S.C. 379j(d)(2)(A) and (e)(2)(A))). An affiliate is defined by
section 737(12) of the act (21 U.S.C. 379i(12)) as a business entity
that has a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to control,
the other business entity; or
(B) a third party controls, or has power to control, both of the
business entities.''
A business headquartered in the United States must demonstrate that
it meets the $100 million threshold by submitting a certified copy of
its most-recent Federal (U.S.) income tax return. A business
headquartered outside the United States must demonstrate that it meets
the $100 million threshold by submitting a National Taxing Authority
Certification from the foreign equivalent of the U.S. Internal Revenue
Service. Under the guidance, both U.S. and foreign businesses should
provide FDA with contact information, identify all of their affiliates,
and certify that the information they provide to FDA is complete and
accurate.
FDA is making this final guidance document immediately available.
Prior public participation is not feasible because it implements
statutory requirements that require immediate implementation. This
guidance is necessary to help effect such implementation.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on FY 2008 medical device user fee small
business qualification and certification. 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 requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``FY 2008 Medical Device User Fee Small Business
Qualification and Certification,'' you may either send an e-mail
request to [email protected] to receive an electronic copy of the
document or send a fax request to 240-276-3151 to receive a hard copy.
Please use the document number 2008 to identify the guidance you are
requesting.
Persons interested in obtaining a copy of the guidance may do so by
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 device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://www.fda.gov/cdrh. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
[[Page 60025]]
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections
of information in this guidance were approved under OMB control number
0910-0613 (approval expires April 16, 2008).
This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
Form FDA 3602 have been approved under OMB Control No. 0910-0508
(approval expires January 31, 2010).
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5226 Filed 10-18-07; 3:08 pm]
BILLING CODE 4160-01-S