E6-18198. Agency Information Collection Activities; Proposed Collection; 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 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 the proposed collection of information that will permit an applicant to certify that it qualifies as a “small business” within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA).

DATES:

Submit written or electronic comments on the collection of information by January 2, 2007.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. 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 the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 practical utility; (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.

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

MDUFMA 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 through 43786), 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 (premarket approval (PMA), product development protocol (PDP), biologic 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 a 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.

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 Burden¹

FDA Form Number	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
3602	2,000	1	2,000	1	2,000
Total					2,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden is based on the number of applications received in the last 3 years.

Dated: October 24, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.