[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66544-66545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no06-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0327]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 15, 2006.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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.
Medical Device User Fee and Modernization Act Small Business
Qualification Certification (Form FDA 3602)--(OMB Control Number 0910-
0508)--Extension
The Medical Device User Fee and Modernization Act (MDUFMA) small
business qualification certification form (Form FDA 3602), 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 license 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 the guidance document entitled
``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.
In the Federal Register of August 29, 2006 (71 FR 51196), FDA
published a 60-day notice soliciting comments on the information
collection provisions. In response to that notice, no comments were
received.
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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FDA Form Annual Frequency per Total Annual Hours per
Number No. of Respondents Response Responses Response Total Hours
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3602 2,000 1 2,000 1 2,000
Total .................... .................... .................... ................. 2,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 66545]]
The burden is based on the number of applications received in the
last 3 years.
Dated: November 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19285 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S