[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:

------------------------------------------------------------------------
                                             FY 2008
   Application Type    -------------------------------------------------
                              Standard Fee            Small Business
------------------------------------------------------------------------
Premarket application                  $185,000                  $46,250
 (PMA, BLA, PDP, or
 PMR)
------------------------------------------------------------------------
Panel-track PMA                        $138,750                  $34,688
 supplement
------------------------------------------------------------------------
BLA efficacy                           $185,000                  $46,250
 supplement
------------------------------------------------------------------------
180-day PMA supplement                  $27,750                   $6,938
------------------------------------------------------------------------
Real-time PMA                           $12,950                   $3,238
 supplement
------------------------------------------------------------------------
510(k) premarket                         $3,404                   $1,702
 notification
------------------------------------------------------------------------
30-day notice                            $2,960                   $1,480
------------------------------------------------------------------------
513(g) request                           $2,498                   $1,249
------------------------------------------------------------------------
Periodic reporting on                    $6,475                   $1,619
 a class III device
------------------------------------------------------------------------
Establishment
 registration                                $1,706
------------------------------------------------------------------------

    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