[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Page 58690-58691]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0311]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 10, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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.

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

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

    Medical Device User Fee and Modernization Act (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 
will publish this guidance by August 1, 2003.
    Respondents will be businesses or other for-profit organizations.
    In the Federal Register of July 18, 2003 (68 FR 42742), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

[[Page 58691]]

    FDA estimates the burden for this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                         Annual Frequency per   Total Annual
 FDA Form Number    No. of Respondents         Response           Responses     Hours per Response   Total 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: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25752 Filed 10-9-03; 8:45 am]