[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66544-66545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0327]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Medical Device User Fee and 
Modernization Act Small Business Qualification Certification (Form FDA 
3602)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 15, 2006.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device User Fee and Modernization Act Small Business 
Qualification Certification (Form FDA 3602)--(OMB Control Number 0910-
0508)--Extension

    The Medical Device User Fee and Modernization Act (MDUFMA) small 
business qualification certification form (Form FDA 3602), amends the 
Federal Food, Drug, and Cosmetic Act to provide for user fees for 
certain medical device applications. FDA published a Federal Register 
notice on August 2, 2006 (71 FR 43784), announcing fees for fiscal year 
(FY) 2007. To avoid harming small businesses, MDUFMA provides for 
reduced or waived fees for applicants who qualify as a ``small 
business.'' This means there are two levels of fees, a standard fee, 
and a reduced or waived small business fee.
    For FY 2006, you can qualify for a small business fee discount 
under MDUFMA if you reported gross receipts or sales of no more than 
$100 million on your Federal income tax return for the most recent tax 
year. If you have any affiliates, partners, or parent firms, you must 
add their gross receipts or sales to yours and the total must be no 
more than $100 million. If your gross receipts or sales are no more 
than $30 million (including all of your affiliates, partners, and 
parent firms), you will also qualify for a waiver of the fee for your 
first (ever) premarket application (PMA, product development protocol 
(PDP), biologics license application (BLA), or premarket report). An 
applicant must pay the full standard fee unless it provides evidence 
demonstrating to FDA that it meets the ``small business'' criteria. The 
evidence required by MDUFMA is a copy of the most recent Federal income 
tax return of the applicant, and any affiliate, partner, or parent 
firm. FDA will review these materials and decide whether an applicant 
is a ``small business'' within the meaning of MDUFMA.
    Form FDA 3602 is available in the guidance document entitled 
``Guidance for Industry and FDA: FY 2006 MDUFMA Small Business 
Qualification Worksheet and Certification.'' This guidance describes 
the criteria FDA will use to decide whether an entity qualifies as a 
MDUFMA small business and will help prospective applicants understand 
what they need to do to meet the small business criteria for FY 2006 
and subsequent fiscal years.
    In the Federal Register of August 29, 2006 (71 FR 51196), FDA 
published a 60-day notice soliciting comments on the information 
collection provisions. In response to that notice, no comments were 
received.
    Description of Respondents: Respondents will be businesses or other 
for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  FDA Form                         Annual Frequency per      Total Annual          Hours per
   Number     No. of Respondents         Response              Responses            Response        Total Hours
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3602                        2,000                     1                 2,000                  1           2,000
Total        ....................  ....................  ....................  .................           2,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 66545]]

    The burden is based on the number of applications received in the 
last 3 years.

    Dated: November 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19285 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S