Federal Register: October 23, 2009 (Volume 74, Number 204)
DOCID: fr23oc09-49 FR Doc E9-25538
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2009-N-0486]
NOTICE: NOTICES
DOCID: fr23oc09-49
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities; Proposed Collection;
DATES: Submit written or electronic comments on the collection of information by December 22, 2009.
DOCUMENT 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. This notice solicits comments on FDA Forms 3602 and FDA Form 3602A which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
SUMMARY:
Agency Information Collection Activities; Proposals, Submissions, and Approvals
DOCUMENT BODY 2:
Comment Request; Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification
SUPPLEMENTAL 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 60day 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 these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's functions, including whether the information will have
practicalutility; (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.
Guidance for Industry, FDA, and Foreign Governments: FY 2010 Medical
Device User Fee Small Business Qualification and Certification FD&C Act Section 738 (OMB Control Number 09100508)Extension
Section 101 of the Medical Device User Fee and Modernization Act (MDUFMA) amends the Federal Food, Drug, and Cosmetic Act (the act) to provide for user fees for certain medical device applications. FDA published a Federal Register notice on August 3, 2009 (74 FR 38444), announcing fees for fiscal year (FY) 2010. 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. FDA From 3602 For Domestic Small Business Applicants
For FY 2010, 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, (product development protocol,
biologics licensing application, 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
[[Page 54827]]
materials and decide whether an applicant is a ``small business'' within the meaning of MDUFMA.
FDA Form 3602A For Foreign Small Business Applicants
The 2007 Amendments provide an alternative way for a foreign business to qualify as a small business eligible to pay a
significantlylower fee when a medical device user fee must be paid.
Before passage of the 2007 Amendments, the only way a business could qualify as a small business was to submit a Federal (U.S.) income tax return showing its gross receipts or sales that did not exceed a statutory threshold, currently, $100 million. If a business could not provide a Federal income tax return, it did not qualify as a small business and had to pay the standard (full) fee. Because many foreign businesses have not, and cannot, file a Federal (U.S.) income tax return, this requirement has effectively prevented those businesses from qualifying for the small business fee rates. Thus, foreign governments, including the European Union, have objected.
In lieu of a Federal income tax return, the 2007 Amendments will allow a foreign business to qualify as a small business by submitting a certification from its national taxing authority, the foreign equivalent of our Internal Revenue Service. This certification, referred to as a ``National Taxing Authority Certification,'' must:
Both FDA Forms 3602 and 3602A are available in the guidance
document, ``Guidance for Industry, FDA and Foreign Governments: FY 2010
MDUFMA Small Business Qualification and Certification'' , available on
the Internet at http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/UCM179257.pdf. 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 2010.
FDA estimates the burden of this collection of information as follows:
Table 1.Estimated Annual Reporting Burden\1\
Number of Annual Frequency Total Annual Hours per
FDA Form No. Respondents per Response Responses Response Total Hours
3602 3,000 1 3,000 1 3,000
3602A 340 1 340 1 340 Sections I and II
3602A 33 7 231 1 231 Section III
TOTALS 3,571
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Form 3602 burden is based on the number of applications received in the last 3 years. FDA believes most entities that submit FDA Form 3602A will not have any affiliates, and very few will have more than three or four affiliates. Based on our experience with FDA Form 3602A, FDA believes each business will require 1 hour to complete Sections I and II. FDA does not have any data on the time that will be required to complete Section III, the National Taxing Authority Certification, since there is a different tax verification process by each country's National Taxing Authority.
The information collection for FDA Form 3602 is currently approved
under OMB control number 09100508. The information collection for FDA
Form 3602A is currently approved under OMB control number 09100613.
With this request for approval, FDA is requesting to consolidate OMB
approvals 09100508 and 09100613 into one information collection using the OMB control number 09100508.
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E925538 Filed 102209; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Denver Presley, Jr., Office of Information Management (HFA710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3017963793.