
[Federal Register: October 23, 2009 (Volume 74, Number 204)]
[
Notices]               
[Page 54826-54827]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc09-49]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2009-N-0486]



 
Agency Information Collection Activities; Proposed Collection; 

Comment Request; Guidance for Industry, FDA, and Foreign Governments: 

Fiscal Year 2010 Medical Device User Fee Small Business Qualification 

and Certification



AGENCY: Food and Drug Administration, HHS.



ACTION: Notice.



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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.



DATES:  Submit written or electronic comments on the collection of 

information by December 22, 2009.



ADDRESSES: Submit electronic comments on the collection of information 

to: http://www.regulations.gov. Submit written comments on the 

collection of information to the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852. All comments should be identified with the docket 

number found in brackets in the heading of this document.



FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of 

Information Management (HFA-710), Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 301-796-3793.



SUPPLEMENTARY 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 60-day 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 0910-0508)--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 

significantly-lower 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:

     Be in English;

     Be from the national taxing authority of the country in 

which the business is headquartered;

     Provide the business' gross receipts or sales for the most 

recent year, in both the local currency and in U.S. dollars, and the 

exchange rate used in converting local currency to U.S. dollars;

     Provide the dates during which the reported receipts or 

sales were collected; and

     Bear the official seal of the national taxing authority.

    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\

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                                                        Number of         Annual Frequency        Total Annual          Hours per

                  FDA  Form No.                        Respondents          per Response            Responses            Response         Total  Hours

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3602                                                             3,000                     1                 3,000                  1              3,000

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3602A                                                              340                     1                   340                  1                340

Sections I and II

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3602A                                                               33                     7                   231                  1                231

Section III

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TOTALS                                                                                                                                             3,571

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\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 0910-0508. The information collection for FDA 

Form 3602A is currently approved under OMB control number 0910-0613. 

With this request for approval, FDA is requesting to consolidate OMB 

approvals 0910-0508 and 0910-0613 into one information collection using 

the OMB control number 0910-0508.



    Dated: October 16, 2009.

David Horowitz,

Assistant Commissioner for Policy.

[FR Doc. E9-25538 Filed 10-22-09; 8:45 am]

BILLING CODE 4160-01-S
