[Federal Register Volume 68, Number 58 (Wednesday, March 26, 2003)]
[Notices]
[Pages 14664-14665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7088]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0065]


Agency Emergency Processing Under OMB Review; Fiscal Year 2003 
MDUFMA Small Business Qualification Certification (Form FDA 3602)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). 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.

DATES: Fax written comments on the information collection provisions by 
April 25, 2003.

ADDRESSES: Fax written comments on the information collection 
provisions to the Office of Information and Regulatory Affairs, Attn: 
Stuart Shapiro, Desk Officer for FDA, FAX 202-395-6974, or 
electronically mail comments to [email protected]. 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 Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). This information is needed 
immediately so that the agency can decide whether an applicant is a 
``small business'' within the meaning of MDUFMA. A small business is 
eligible for a reduced or waived fee for a medical device application 
or submission that is subject to a user fee under MDUFMA. If an 
applicant is not a small business, it must pay the standard (full) fee 
for any medical device application or submission it submits to FDA. FDA 
is requesting this emergency processing to implement 21 CFR 
738(d)(2)(B) and (e)(2)(B) (Sec.  738(d)(2)(B) and (e)(2)(B)) of the 
Federal Food, Drug, and Cosmetic Act (the act); these provisions were 
added to the act by section 102 of MDUFMA. The use of normal clearance 
procedures would likely result in the prevention or disruption of this 
collection of information, thereby subjecting applicants who would

[[Page 14665]]

otherwise qualify as a small business to the statutory requirement to 
pay a standard (full) fee rather than a reduced fee.
    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.

FY 2003 MDUFMA Small Business Qualification Certification (Form FDA 
3602)

    MDUFMA (Public Law 107-250) 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. 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.
    Under MDUFMA, 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 of MDUFMA.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice announcing the availability of the guidance entitled ``FY 2003 
MDUFMA Small Business Qualification Worksheet and Certification.'' The 
guidance describes the criteria FDA will use to decide whether an 
entity qualifies as a MDUFMA small business and helps prospective 
applicants understand what they need to do to meet the criteria for FY 
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\
----------------------------------------------------------------------------------------------------------------
                                                            Annual
                                            No. of        Frequency    Total Annual       Hours per       Total
           FDA Form Number            [chyph]Respondents     per     [chyph]Responses  [chyph]Response    Hours
                                                           Response
----------------------------------------------------------------------------------------------------------------
3602                                           100               1           100                 1          100
----------------------------------------------------------------------------------------------------------------
\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 application, a premarket report, a panel track 
supplement, efficacy supplement, 180-day supplement, or a real time 
supplement to FDA during FY 2003.

    Dated: March 10, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7088 Filed 3-25-03; 8:45 am]
BILLING CODE 4160-01-S