[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Notices]
[Page 58690-58691]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc03-72]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
SUPPLEMENTARY INFORMATION:
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
of MDUFMA.
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
follows:
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]
BILLING CODE 4160-01-S