[Federal Register Volume 68, Number 59 (Thursday, March 27, 2003)]
[Notices]
[Pages 14992-14994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0063]


Medical Devices: Guidance for Industry and FDA: Fiscal Year 2003 
Medical Device User Fee and Modernization Act of 2002 Small Business 
Qualification Worksheet 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 2003 MDUFMA Small Business 
Qualification Worksheet and Certification.'' This guidance explains how 
you can certify that you qualify as a ``small business'' within the 
meaning of the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) and provides a copy of, and instructions for, Form FDA 3602, 
``FY 2003 MDUFMA Small Business Qualification Certification.'' If FDA 
decides that you are a small business, you will be eligible for reduced 
or waived small business fees for medical device applications that you 
submit from October 1, 2002, through September 30, 2003.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``FY 2003 MDUFMA Small 
Business Qualification Worksheet and Certification'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health (CDRH), Food and

[[Page 14993]]

Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two 
self-addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Comments should be identified with the docket number found in 
brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Thomas E. Cardamone, Center for 
Devices and Radiological Health (HFZ-220), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-0806, 
ext. 117.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is providing guidance on how you may qualify as a ``small 
business'' within the meaning of MDUFMA. MDUFMA requires FDA to collect 
a user fee from each person who submits certain medical device 
applications for FDA review. MDUFMA user fees range from $2,187 to 
$154,000, depending on the type of application. The fees for fiscal 
year (FY) 2003 are summarized in table 1 of this document. A ``small 
business'' is eligible for reduced or waived fees.
    To qualify as a small business, your ``gross receipts or sales,'' 
including that of all of your affiliates, partners, and parent firms, 
cannot exceed $30 million. See section 738(d)(2)(A)(i) and (e)(2)(A) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
379j(d)(2)(A)(i) and (e)(2)(A)). When you submit an application that is 
subject to a MDUFMA user fee, you must pay the standard fee unless you 
have provided information to FDA that demonstrates that you are a small 
business.

          Table 1.--FY 2003 Medical Device Review User Fees\1\
------------------------------------------------------------------------
      Application             Standard Fee            Small Business
------------------------------------------------------------------------
Premarket application                  $154,000                  $58,520
 (PMA\1\, PDP\1\,
 BLA\1\)
------------------------------------------------------------------------
Premarket report                       $154,000                  $58,520
 (premarket
 application for a
 reprocessed single-
 use device)
------------------------------------------------------------------------
First premarket                  Not applicable            Fee is waived
 application by a
 small business
------------------------------------------------------------------------
Panel-track supplement                 $154,000                  $58,520
------------------------------------------------------------------------
Efficacy supplement                    $154,000                  $58,520
------------------------------------------------------------------------
180-day supplement                      $33,100                  $12,582
------------------------------------------------------------------------
Real-time supplement                    $11,088                   $4,213
------------------------------------------------------------------------
510(k)                                   $2,187                $2,187\2\
------------------------------------------------------------------------
\1\PMA means premarket approval applications, PDP means product
  development protocol, and BLA means biologics license application
\2\During FY 2003, all 510(k) applicants will pay the standard fee. A
  reduced small business fee will be available beginning FY 2004.

    FDA is making this guidance effective immediately because there is 
a statutory requirement that requires immediate implementation and 
guidance is needed to help effect such implementation. As soon as 
Congress enacts an appropriation authorizing FDA to collect and spend 
MDUFMA user fees, we will begin to collect those fees. You must pay the 
full standard fee unless you demonstrate you are a small business 
(section 738(d)(2)(B) and (e)(2)(B) of the act). You will pay a fee for 
each application you submit on or after October 1, 2002, if that 
application is subject to a fee. If you do not pay a fee when MDUFMA 
requires you to do so, FDA will not file or review your application.

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 small entities and MDUFMA. 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

    You may obtain a copy of ``FY 2003 MDUFMA Small Business 
Qualification Worksheet and Certification'' via your fax machine by 
calling the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. At the first voice prompt press 1 
to enter the system. At the second voice prompt press 1 to order a 
document, then enter the document number (1204) followed by the pound 
sign (). Then follow the remaining voice prompts to complete 
your request.
    You may also obtain a copy of the guidance through the Internet. 
FDA provides this guidance and additional information on MDUFMA at 
http://www.fda.gov/oc/mdufma. FDA periodically updates this site to 
provide you the most current information and guidance concerning the 
MDUFMA program.

IV. Paperwork Reduction Act

    This draft guidance contains a collection of information that 
requires clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

V. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance. Two 
copies of any mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Electronic comments may be submitted at http://www.fda.gov/dockets/ecomments. The guidance document and received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.


[[Page 14994]]


    Dated: March 12, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-7374 Filed 3-25-03; 8:45 am]
BILLING CODE 4160-01-S