[Federal Register: July 18, 2003 (Volume 68, Number 138)]
[Page 42742-42743]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Docket No. 2003N-0311

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.


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. The proposed collection of information 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), will 
help the applicant organize the information FDA needs to verify each 
certification, and will collect contact information to facilitate rapid 
resolution of any questions FDA may have concerning information the 
applicant has provided. In the Federal Register of March 26, 2003 (68 
FR 14664), FDA published a notice announcing OMB's approval of this 
collection of information (OMB control number 0910-0508). Since this 
was an emergency approval that expires on October 31, 2003, FDA is 
following the normal PRA clearance procedures by issuing this notice.

DATES: Submit written or electronic comments on the collection of 
information September 16, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.fda.gov/dockets/edockethome. Submit 
written comments on the collection of information to the Divsion 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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: (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. The initial fees 
(for fiscal year (FY) 2003) are set by statute; FDA will publish a 
Federal Register notice by August 1, 2003, announcing the fees for FY 
2004. 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.
    Presently, a ``small business'' is an applicant who reported no 
more than $30 million ``gross receipts or sales'' on its Federal income 
tax return for the most recent tax year; the applicant must count the 
``gross receipts or sales'' of all of its affiliates, partners, or 
parent firms when calculating whether it meets the $30 million 
threshold. 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 
    Form FDA 3602 will be available in a forthcoming guidance document, 
``MDUFMA Small Business Qualification Worksheet and Certification.'' 
This guidance will describe 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 2004 and subsequent fiscal years. FDA 

[[Page 42743]]

publish this guidance by August 1, 2003.
    Respondents will be businesses or other for-profit organizations. 
FDA estimates the burden of this information collection as follows:

                                Table 1. -- Estimated Annual Reporting Burden\1\
                                            No. of        Frequency    Total Annual       Hours per       Total
           FDA Form Number            [chyph]Respondents     per     [chyph]Responses  [chyph]Response    Hours
3602                                         3,000               1         3,000                 1        3,000
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on conversations with industry, trade 
association representatives, and from internal FDA estimates. This 
represents FDA's estimate on the number of small businesses that will 
submit a premarket notification, a premarket application, a premarket 
report, a panel track supplement, efficacy supplement, 180-day 
supplement, or a real time supplement to FDA during a single fiscal 
year from FY 2004 through 2007.

    Dated: July 11, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18160 Filed 7-17-03; 8:45 am]