[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51196-51197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0327]


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 October 30, 2006.

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 
Management Programs (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 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), 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 licensing 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 guidance document, ``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 Hours                                             .................  ....................  .................  .................              2,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 51197]]

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

    Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14267 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S