[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63765-63766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0426]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed collection of 
information that will permit an applicant to certify that it qualifies 
as a ``small business'' within the meaning of the Medical Device User 
Fee and Modernization Act (MDUFMA).

DATES:  Submit written or electronic comments on the collection of 
information by January 2, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance

[[Page 63766]]

the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

MDUFMA Small Business Qualification Certification (Form FDA 3602)--(OMB 
Control Number 0910-0508)--Extension

    MDUFMA 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 through 43786), 
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 (premarket approval (PMA), product 
development protocol (PDP), biologic 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 a 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.
    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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                         No. of        Annual Frequency     Total Annual        Hours per
 FDA Form Number      Respondents        per Response        Responses           Response         Total Hours
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3602                           2,000                  1              2,000                  1              2,000
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Total                                                                                                      2,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

    Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18198 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S